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Sign in to claim this brandGE Hualun Medical Systems Co., Ltd
China·CN-MF-000001189
Last updated May 30, 2026
What GE Hualun Medical Systems Co., Ltd makes
GE Hualun Medical Systems Co., Ltd manufactures stationary and mobile diagnostic imaging systems, including digital and analogue basic diagnostic x-ray systems, mobile general-purpose fluoroscopic x-ray systems, stationary gamma camera systems, stationary angiographic x-ray systems, and full-body CT systems. The company also produces single-use vascular dilators.
The manufacturer's devices are classified as Class II, Class IIa, and Class IIb and are listed in regulatory databases including Eudamed, FDA 510(k), and FDA UDI. GE Hualun Medical Systems Co., Ltd is based in China.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does GE Hualun Medical Systems Co., Ltd make?
GE Hualun Medical Systems Co., Ltd manufactures stationary and mobile diagnostic imaging systems, including digital and analogue basic diagnostic x-ray systems, mobile general-purpose fluoroscopic x-ray systems, stationary gamma camera systems, stationary angiographic x-ray systems, and full-body CT systems. The company also produces single-use vascular dilators.
Where is GE Hualun Medical Systems Co., Ltd based?
GE Hualun Medical Systems Co., Ltd is based in China, as indicated by the country code CN in the manufacturer data.
Which regulatory registries list devices from GE Hualun Medical Systems Co., Ltd?
Devices from GE Hualun Medical Systems Co., Ltd are listed in Eudamed, FDA 510(k), and FDA UDI regulatory databases, as specified in the LISTED IN field of the device data.
How are the devices from GE Hualun Medical Systems Co., Ltd classified?
The devices manufactured by GE Hualun Medical Systems Co., Ltd are classified as Class II, Class IIa, and Class IIb, according to the DEVICE CLASSES field in the provided data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- 19, ChangJiang Road, WUXI, China
- Website
- gehealthcare.com
- —
- —
- [email protected]
- Phone
- +1(999)999-9999
- PRRC Contact
- Yanli Sun
- EUDAMED SRN
- CN-MF-000001189
- FDA FEI Number
- —
- DUNS Number
- 554408665
Catalogue (91)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Brivo | NM 615 | FDA UDI | Class II | Active |
| D630 to D670 DR Upgrade | H2401DS | FDA UDI | Class II | Active |
| Flashpad HD | 4343 | FDA UDI | Class II | Active |
| Optima | IGS Mega | FDA UDI | Class II | Active |
| Optima | XR646 HD | FDA UDI | Class II | Active |
| Wireless Dr Imaging Option | WDR1 | FDA UDI | Class II | Active |
| Oec | Brivo Essential | FDA UDI | Class II | Active |
| Oec | Brivo Prime | FDA UDI | Class II | Active |
| Oec | One | FDA UDI | Class II | Active |
| Oec | Brivo Plus | FDA UDI | Class II | Active |
| D630 Upgrade | H2401XF | FDA UDI | Class II | Active |
| Optima | IGS Ultra | FDA UDI | Class II | Active |
| Discovery | XR656 HD Upgrade | FDA UDI | Class II | Active |
| Discovery | XR656 | FDA UDI | Class II | Active |
| Discovery | XR656 HD Upgrade | FDA UDI | Class II | Active |
| Brivo | XR385 | FDA UDI | Class II | Active |
| Optima | IGS 330 001 | FDA UDI | Class II | Active |
| Proteus | XRa | FDA UDI | Class II | Active |
| Discovery | XR656 | FDA UDI | Class II | Active |
| Optima | XR646 HD Upgrade | FDA UDI | Class II | Active |
| Oec | Elite MiniView | FDA UDI | Class II | Active |
| Optima | IGS 320 001 | FDA UDI | Class II | Active |
| Optima | XR646 HD Upgrade | FDA UDI | Class II | Active |
| Brivo 615 | 5376496-15 | FDA UDI | Class II | Active |
| E8Cs-RS | H48062AF | EUDAMEDFDA UDI | Class IIa | Active |
| Definium Tempo Select | B2400UDI | EUDAMEDFDA UDI | Class IIb | Active |
| L4-20t-RS | H48062AJ | EUDAMEDFDA UDI | Class IIa | Active |
| Rab7-D | H48062AN | EUDAMEDFDA UDI | Class IIa | Active |
| 9100c NXT | M9100175 | EUDAMED | Class IIb | Active |
| L6-12-Rs | H48062AC | EUDAMEDFDA UDI | Class IIa | Active |
| Vivid T8, Vivid T9 | Vivid T9 v206/5876948 | EUDAMEDFDA UDI | Class IIa | Active |
| Nm 830 | 5797112 PCM | EUDAMED | Class IIa | Active |
| Aurora | H2412AL, H2412AN | EUDAMED | Class IIb | Active |
| L4-12t-RS | H48062AB | EUDAMEDFDA UDI | Class IIa | Active |
| Nm/Ct 870 Dr | 5797111 | EUDAMED | Class IIb | Active |
| 4Sc-RS | H48062AU | EUDAMED | Class IIa | Active |
| Discovery XR656 HD with VolumeRad | K191699 | FDA 510(k) | Class II | Active |
| Optima XR646 | K143270 | FDA 510(k) | Class II | Active |
| OEC Elite MiniView | K171800 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Discovery XR656 HD | K172869 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Optima XR646 HD | K173612 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| OEC One ASD | OEC One ASD | EUDAMEDFDA UDI | Class IIb | Active |
| L3-12-D | H48062AA | EUDAMEDFDA UDI | Class IIa | Active |
| Carevance H1 | 8180000-010 | EUDAMED | Class IIb | Active |
| Logiq | LOGIQ e TP | EUDAMEDFDA UDI | Class IIa | Active |
| Definium Pace Select | B2604CAB | EUDAMEDFDA UDI | Class IIb | Active |
| Carevance D19 | 8180000-003 | EUDAMED | Class IIb | Active |
| Logiq F | 5976240 | EUDAMED | Class IIa | Active |
| Definium Pace Select ET | B4600UDI | EUDAMEDFDA UDI | Class IIb | Active |
| OEC One CFD | 7999000PCM | EUDAMEDFDA UDI | Class IIb | Active |
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FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 26, 2026 | Z-2154-2026 | — | open, classified | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. |
| Mar 26, 2026 | Z-2152-2026 | — | open, classified | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. |
| Mar 26, 2026 | Z-2149-2026 | — | open, classified | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. |
| Mar 26, 2026 | Z-2151-2026 | — | open, classified | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. |
| Mar 26, 2026 | Z-2155-2026 | — | open, classified | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. |
| Mar 26, 2026 | Z-2150-2026 | — | open, classified | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. |
| Mar 26, 2026 | Z-2153-2026 | — | open, classified | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. |
| Feb 3, 2026 | Z-1590-2026 | — | open, classified | There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. |
| Jan 30, 2026 | Z-1569-2026 | — | open, classified | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. |
| Jan 30, 2026 | Z-1571-2026 | — | open, classified | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. |
| Jan 30, 2026 | Z-1570-2026 | — | open, classified | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. |
| Oct 24, 2025 | Z-0875-2026 | — | open, classified | Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j). |
| Sep 18, 2025 | Z-0157-2026 | — | open, classified | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. |
| Sep 18, 2025 | Z-0156-2026 | — | open, classified | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. |
| Sep 18, 2025 | Z-0155-2026 | — | open, classified | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. |
| Aug 22, 2025 | Z-0231-2026 | — | open, classified | If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use. |
| Jul 2, 2025 | Z-2341-2025 | — | open, classified | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user. |
| Jul 2, 2025 | Z-2342-2025 | — | open, classified | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user. |
| Jun 20, 2025 | Z-2308-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2299-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2320-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2319-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2311-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2300-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2309-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2307-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2303-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2318-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2305-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2316-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2313-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2315-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2302-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2304-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2306-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2312-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2310-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2301-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2314-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| Jun 20, 2025 | Z-2317-2025 | — | open, classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. |
| May 23, 2025 | Z-2133-2025 | — | open, classified | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual. |
| May 23, 2025 | Z-2132-2025 | — | open, classified | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual. |
| May 23, 2025 | Z-2131-2025 | — | open, classified | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual. |
| May 23, 2025 | Z-2130-2025 | — | open, classified | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual. |
| Mar 21, 2025 | Z-1819-2025 | — | open, classified | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| Mar 21, 2025 | Z-1820-2025 | — | open, classified | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| Mar 6, 2025 | Z-1555-2025 | — | open, classified | The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. |
| Mar 6, 2025 | Z-1556-2025 | — | open, classified | The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. |
| Feb 18, 2025 | Z-1298-2025 | — | open, classified | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls. |
| Feb 18, 2025 | Z-1300-2025 | — | open, classified | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls. |
| Feb 18, 2025 | Z-1301-2025 | — | open, classified | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls. |
| Feb 18, 2025 | Z-1299-2025 | — | open, classified | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls. |
| Feb 18, 2025 | Z-1297-2025 | — | open, classified | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls. |
| Feb 18, 2025 | Z-1303-2025 | — | open, classified | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls. |
| Feb 18, 2025 | Z-1302-2025 | — | open, classified | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls. |
| Jan 28, 2025 | Z-1045-2025 | — | open, classified | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached. |
| Jan 28, 2025 | Z-1046-2025 | — | open, classified | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached. |
| Jan 28, 2025 | Z-1043-2025 | — | open, classified | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached. |
| Jan 28, 2025 | Z-1044-2025 | — | open, classified | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached. |
| Dec 6, 2024 | Z-0918-2025 | — | open, classified | There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time. |
| Nov 25, 2024 | Z-0813-2025 | — | open, classified | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track. |
| Nov 25, 2024 | Z-0811-2025 | — | open, classified | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track. |
| Nov 25, 2024 | Z-0812-2025 | — | open, classified | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track. |
| Nov 18, 2024 | Z-0816-2025 | — | open, classified | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| Nov 18, 2024 | Z-0814-2025 | — | open, classified | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| Nov 18, 2024 | Z-0817-2025 | — | open, classified | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| Nov 18, 2024 | Z-0818-2025 | — | open, classified | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| Nov 18, 2024 | Z-0815-2025 | — | open, classified | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| Oct 28, 2024 | Z-0518-2025 | — | open, classified | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. |
| Oct 28, 2024 | Z-0520-2025 | — | open, classified | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. |
| Oct 28, 2024 | Z-0517-2025 | — | open, classified | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. |
| Oct 28, 2024 | Z-0519-2025 | — | open, classified | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. |
| Jun 14, 2024 | Z-2471-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2479-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2483-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2462-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2477-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2472-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2474-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2469-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2478-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2480-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2475-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2481-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2470-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2465-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2468-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2466-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2461-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2473-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2464-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2476-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2482-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2467-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2459-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2460-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2484-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Jun 14, 2024 | Z-2463-2024 | — | open, classified | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Nov 16, 2022 | Z-0729-2023 | — | open, classified | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level. |
| Nov 16, 2022 | Z-0732-2023 | — | open, classified | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level. |