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GE Healthcare

United States·US-MF-000001862

Last updated September 17, 2026

What GE Healthcare makes

GE Healthcare manufactures radiological PACS software, diagnostic x-ray digital imaging system workstations, and medical image management systems, including products such as LOGIQ E, MyoSPECT and MyoSpect ES, Digital Expert Access, Centricity PACS, ViewPoint, Universal Viewer, Senographe Pristina, and DATEX-OHMEDA S/5 EEG modules and accessories.

The company's devices span Class I, II, III, and IIa classifications and are listed in regulatory registries including Eudamed, FDA 510(k), FDA PMA, and FDA UDI. GE Healthcare is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does GE Healthcare manufacture?

GE Healthcare manufactures radiological PACS software, diagnostic x-ray digital imaging system workstations, and medical image management systems, as these are the device categories explicitly listed in the provided data. Examples include LOGIQ E, MyoSPECT and MyoSpect ES, Digital Expert Access, Centricity PACS, ViewPoint, Universal Viewer, Senographe Pristina, and DATEX-OHMEDA S/5 EEG modules and accessories. These products fall under the core categories of imaging and information systems used in clinical settings for acquiring, storing, and managing medical images.

Where is GE Healthcare based?

GE Healthcare is based in the United States, as explicitly stated in the SUMMARY section of the provided data. This indicates the company’s headquarters or primary operational location is within the US, which is relevant for understanding its regulatory jurisdiction and market focus.

Which regulatory registries list GE Healthcare's devices?

GE Healthcare's devices are listed in Eudamed, FDA 510(k), FDA PMA, and FDA UDI, as specified in the LISTED IN field of the device data. These registries are used to track medical devices in the European Union and the United States, reflecting the company’s compliance with regulatory requirements in those markets for device identification and post-market surveillance.

How are GE Healthcare's devices classified?

GE Healthcare's devices span Class I, II, III, and IIa classifications, as stated in the DEVICE CLASSES field. This indicates a range of risk-based classifications under regulatory frameworks such as the EU MDR and FDA systems, where Class I represents low risk and Class III represents high risk, with Class IIa being a medium-risk category in the EU system. The inclusion of multiple classes reflects the diversity of the company’s product portfolio, from software to imaging hardware and EEG modules.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 500, W Monroe Street, Chicago, United States
Website: gehealthcare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)437-1171
PRRC Contact: Elizabeth Mathew
EUDAMED SRN: US-MF-000001862
FDA FEI Number: 3004526608
DUNS Number: 054324257

Catalogue (168)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
Optima Nm/Ct 640	K121019	FDA 510(k)	Class II	Active
Logiq S7 Expert, Logiq S7 Pro	K122114	FDA 510(k)	Class II	Active
Modification To: Datex-Ohmeda S/5 Entropy Module, E-Entropy And Accessories	K061907	FDA 510(k)	Class II	Active
Sample Imaging for Senographe Pristina	K190809	FDA 510(k)	Class II	Active
LOGIQ P9 and LOGIQ P7	K161047	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Memory Module, E-Mem	K052756	FDA 510(k)	Class II	Active
LOGIQ P9 and LOGIQ P7	K163596	FDA 510(k)	Class II	Active
Senolris	K160937	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Cardiac Output And Svo2 Module, E-Copsv And Accessories	K052977	FDA 510(k)	Class II	Active
Ge Lightspeed Ct750 Hd (lightspeed 8.0)	K081105	FDA 510(k)	Class II	Active
CARESCAPE Central Station V2	K162012	FDA 510(k)	Class II	Active
Ge Signa Excite Mr Surgical Option	K043262	FDA 510(k)	Class II	Active
Logiq P9; Logiq P7	K181783	FDA 510(k)	Class II	Active
Datex-Ohmeda Network And Icentral '05, Sales Revision 4.3	K052972	FDA 510(k)	Class II	Active
Logiq S7 Expert, Logiq S7 Pro	K141261	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Device Interfacing Solution	K051634	FDA 510(k)	Class II	Active
Voluson E6, Voluson E8, Voluson E10	K192159	FDA 510(k)	Class II	Active
Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System	K112213	FDA 510(k)	Class II	Active
C2-9-D Ultrasound Transducer	K122515	FDA 510(k)	Class II	Active
Disposable Temperature, Skin And Esophageal Probes	K051873	FDA 510(k)	Class II	Active
LOGIQ E10s, LOGIQ Fortis	K211524	FDA 510(k)	Class II	Active
Invenia ABUS Viewer	K180641	FDA 510(k)	Class II	Active
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System	K152567	FDA 510(k)	Class II	Active
Panda iRes Warmer, Giraffe Warmer	K201628	FDA 510(k)	Class II	Active
LOGIQ S7 Expert	K160182	FDA 510(k)	Class II	Active
Xeleris 4.0 Processing and Review Workstation	K153355	FDA 510(k)	Class II	Active
Senographe Pristina	K162268	FDA 510(k)	Class II	Active
Fullcard Analysis	K061587	FDA 510(k)	Class II	Active
Ge Logiq I, Logiq E And Vivid E	K113690	FDA 510(k)	Class II	Active
Ohmeda Medical Giraffe Omnibed	K071175	FDA 510(k)	Class II	Active
Discovery Nm 630	K111445	FDA 510(k)	Class II	Active
Advantage Sim Md	K052345	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 With N-Disvent..02	K070421	FDA 510(k)	Class II	Active
SenoBright HD	K172404	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Compact Critical Care Monitor With L-Cicu05 And L-Cicu05a Software	K071020	FDA 510(k)	Class II	Active
Mammo Workstation	K143361	FDA 510(k)	Class II	Active
Ge Logiq E9 Bt2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	K092271	FDA 510(k)	Class II	Active
Digital Expert Access with Remote Scanning	K232346	FDA 510(k)	Class II	Active
Advance Vessel Analysis Ii	K060779	FDA 510(k)	Class II	Active
Voluson I/E	K131937	FDA 510(k)	Class II	Active
Logiq P3	K112371	FDA 510(k)	Class II	Active
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems	K142472	FDA 510(k)	Class II	Active
Voluson E6/E8/E8expert/E8expert Limited Edition/E10	K131267	FDA 510(k)	Class II	Active
Venue 50	K133431	FDA 510(k)	Class II	Active
Ge Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems With Cathlab Frontiers Solutions	K122457	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Cardiac Output Module, E-Cop And Accessories	K052976	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 E-Psm(p) Module (consisting Of E-Psm, E-Psmp And E-Intpsm Modules) And Accessories	K062576	FDA 510(k)	Class II	Active
Unity Network ID	K142840	FDA 510(k)	Class II	Active
Voluson E6/E8/E8expert/E10	K122327	FDA 510(k)	Class II	Active
Digital Expert Access	5941611	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

GE Medical Systems SCS FR

Importers

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Authorities

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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.

There are 783 recall records for GE Healthcare, with the earliest initiated on 2005-04-18 and the most recent on 2026-02-27. The statuses of these recalls include completed, open, classified, and terminated. The reasons given in the records include unclear guidance in service manuals leading to potential table drops during service, possible misdiagnosis due to signal homogeneity issues in BRAVO applications, unintended patient orientation or scan settings with Intelligent Protocoling, required torque checks on bolted joints of the Revolution CT scanner, cable failures affecting gantry rotation in the DST-XL Camera, inaccurate dimension measurements in M-Mode when pan-Zoom is activated in Voluson E8 Ultrasound Systems, improperly adjusted hand grips on Revolution XRD X-ray systems that may dislodge, potential ECG calculation issues following PDM disconnect/reconnect cycles with Carescape Bx50 monitors, reduced energy delivery during defibrillation due to ECG trunk cables and leadwires, potential reversal of O2 and air cylinder pressure transducer connections, display of incorrect patient data in the Results Viewer on the AW Server, and a missing quality control test during installation of Revolution CT scanner software.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 27, 2026	Z-1767-2026	—	open, classified	Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
Jan 16, 2026	Z-1475-2026	—	open, classified	Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
Feb 19, 2025	Z-1487-2025	—	open, classified	There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Feb 19, 2025	Z-1486-2025	—	open, classified	There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Feb 19, 2025	Z-1485-2025	—	open, classified	There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Feb 19, 2025	Z-1484-2025	—	open, classified	There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Feb 19, 2025	Z-1483-2025	—	open, classified	There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Oct 3, 2024	Z-0318-2025	—	open, classified	GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access the system and potentially manipulate patient data.
Aug 29, 2024	Z-0039-2025	—	open, classified	GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.
Aug 5, 2024	Z-3214-2024	—	open, classified	GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.
Jul 23, 2024	Z-3160-2024	—	open, classified	Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.
Sep 14, 2023	Z-0140-2024	—	open, classified	GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Sep 14, 2023	Z-0139-2024	—	open, classified	GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Sep 14, 2023	Z-0138-2024	—	open, classified	GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Sep 8, 2023	Z-0142-2024	—	open, classified	When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
Sep 8, 2023	Z-0143-2024	—	open, classified	When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
Mar 28, 2023	Z-1501-2023	—	open, classified	GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
Mar 28, 2023	Z-1500-2023	—	open, classified	GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
Mar 28, 2023	Z-1502-2023	—	open, classified	GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
Jul 15, 2022	Z-1566-2022	—	open, classified	Inaccurate Distance and Area measurements with use of Global Stack viewport.
Jun 24, 2022	Z-1430-2022	—	open, classified	Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
Jun 14, 2022	Z-1466-2022	—	terminated	The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
Jun 8, 2022	Z-1333-2022	—	open, classified	Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
Jun 2, 2022	Z-1511-2022	—	open, classified	As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.
Jun 1, 2022	Z-1389-2022	—	terminated	There is a potential reversal of the O2 and air cylinder pressure transducer connections.
May 27, 2022	Z-1427-2022	—	open, classified	The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.
May 10, 2022	Z-1265-2022	—	open, classified	The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
Apr 28, 2022	Z-1233-2022	—	open, classified	Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Apr 28, 2022	Z-1229-2022	—	open, classified	Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Apr 28, 2022	Z-1231-2022	—	open, classified	Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Apr 28, 2022	Z-1230-2022	—	open, classified	Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Apr 28, 2022	Z-1232-2022	—	open, classified	Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Apr 25, 2022	Z-1286-2022	—	open, classified	Backup batteries can fail earlier than their estimated life.
Apr 25, 2022	Z-1285-2022	—	open, classified	Backup batteries can fail earlier than their estimated life.
Apr 18, 2022	Z-1227-2022	—	open, classified	Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Apr 18, 2022	Z-1226-2022	—	open, classified	Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Mar 16, 2022	Z-0919-2022	—	completed	Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
Mar 4, 2022	Z-0983-2022	—	open, classified	During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
Feb 18, 2022	Z-0859-2022	—	open, classified	There is potential for the images to be flipped left to right.
Feb 18, 2022	Z-0857-2022	—	open, classified	There is potential for the images to be flipped left to right.
Feb 18, 2022	Z-0860-2022	—	open, classified	There is potential for the images to be flipped left to right.
Feb 18, 2022	Z-0858-2022	—	open, classified	There is potential for the images to be flipped left to right.
Jan 28, 2022	Z-0808-2022	—	open, classified	If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
Dec 23, 2021	Z-0594-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0607-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0606-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0608-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0609-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0590-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0595-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0616-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0611-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0617-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0614-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0601-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0593-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0592-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0602-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0603-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0610-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0598-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0613-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0605-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0618-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0600-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0597-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0619-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0591-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0596-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0615-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0604-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0612-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0620-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0621-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Dec 23, 2021	Z-0599-2022	—	open, classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Nov 4, 2021	Z-0521-2022	—	open, classified	The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Nov 4, 2021	Z-0524-2022	—	open, classified	The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Nov 4, 2021	Z-0523-2022	—	open, classified	The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Nov 4, 2021	Z-0518-2022	—	open, classified	The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Nov 4, 2021	Z-0522-2022	—	open, classified	The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Nov 4, 2021	Z-0520-2022	—	open, classified	The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Nov 4, 2021	Z-0519-2022	—	open, classified	The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Oct 15, 2021	Z-0329-2022	—	open, classified	There is a potential to display incomplete patient imaging study.
Aug 26, 2021	Z-0132-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 26, 2021	Z-0139-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 26, 2021	Z-0135-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 26, 2021	Z-0138-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 26, 2021	Z-0133-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 26, 2021	Z-0137-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 26, 2021	Z-0140-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 26, 2021	Z-0141-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 26, 2021	Z-0134-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 26, 2021	Z-0136-2022	—	completed	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Aug 12, 2021	Z-0012-2022	—	terminated	A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
Aug 6, 2021	Z-2502-2021	—	open, classified	Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Aug 6, 2021	Z-2503-2021	—	open, classified	Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Aug 2, 2021	Z-2595-2021	—	open, classified	The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
Aug 2, 2021	Z-2596-2021	—	open, classified	The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
Jun 30, 2021	Z-2022-2021	—	open, classified	When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
Jun 30, 2021	Z-2023-2021	—	open, classified	When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.