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Sign in to claim this brandPhilips North America LLC
United States·US-MF-000033010
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3630, SW 47th Ave, Gainesville, United States
- Website
- n/a
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Kenneth Revennaugh
- EUDAMED SRN
- US-MF-000033010
- FDA FEI Number
- 3016618143
- DUNS Number
- 001291111
Catalogue (703)
Page 1 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SmartLinx Vitals Plus | SL-VP-BPAP-HW | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-BPAP-HW | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-BPAP-HW | FDA UDI | Class II | Active |
| Kit, Sample, ETCO2, 3160 | Kit, Sample, EtCO2, 3160 | FDA UDI | Class II | Unknown |
| SmartLinx Vitals Plus | SL-VP-BPAP-HW | FDA UDI | Class II | Unknown |
| Invivo | 101759 | FDA UDI | Class II | Active |
| Invivo | 784001 | FDA UDI | Class II | Active |
| Xper Flex Cardio Physiomonitoring System | Xper Flex Cardio FC2020 REV E | FDA UDI | Class II | Unknown |
| Invivo | 45980009795 | FDA UDI | Class II | Active |
| Module, Wireless Spo2, 3160, N4 | 989803153321 | FDA UDI | Class II | Unknown |
| Invivo | 45980069663 | FDA UDI | Class II | Active |
| Capsule Vitals Plus | CAP-VP-NIBPAH-MON-HW | FDA UDI | Class II | Active |
| Invivo | 45353038449 | FDA UDI | Class II | Active |
| Invivo | 45353022873 | FDA UDI | Class II | Active |
| Invivo | 459801508641 | FDA UDI | Class II | Active |
| Invivo | 45353031230 | FDA UDI | Class II | Active |
| Invivo | SENSE Head 8 | FDA UDI | Class II | Active |
| Invivo | 45353030474 | FDA UDI | Class II | Active |
| Capsule Vitals Plus | CAP-VP-NIBPAH-MON-HW | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-NIBPAH-MON-HW | FDA UDI | Class II | Active |
| Xper Flex Cardio Physiomonitoring System | Xper FC2010 Rev E EXCHANGE | FDA UDI | Class II | Active |
| Invivo | 45353025267 | FDA UDI | Class II | Active |
| Expression MR LoFlo Line, Adu Dvd Cannula, Box 100 | LoFlo Line, Adu Dvd Cannula, Box 100 | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-BPAP-HW | FDA UDI | Class II | Active |
| Invivo | 45353020260 | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-NIBPAH-MON-HW | FDA UDI | Class II | Active |
| Invivo | 45353022891 | FDA UDI | Class II | Active |
| Invivo | 45353033812 | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-BPAP-HW | FDA UDI | Class II | Active |
| MR Patient Care Adult NBP Cuff | NiBP Cuff, Single Lumen, Adult | FDA UDI | Class II | Active |
| Invivo | 98960320336 | FDA UDI | Class II | Active |
| Invivo | 45353010118 | FDA UDI | Class II | Active |
| Module, Wireless Ecg, 3160, N2 | 989803153351 | FDA UDI | Class II | Unknown |
| Invivo | 98960320412 | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-BPAP-HW | FDA UDI | Class II | Active |
| Invivo | 98960320369 | FDA UDI | Class II | Active |
| Invivo | 4535-303-8608 | FDA UDI | Class II | Active |
| MR Patient Care Neonatal ECG 3.0 Cable AAMI | Expression MR ECG Leads, AAMI, Neonatal | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-BPAP-HW | FDA UDI | Class II | Active |
| Expression MR LoFlo Sample Line, Neonate Cannula | LoFlo Sample Line, Neo. Cannula, Box 20 | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-NIBPAH-MON-HW | FDA UDI | Class II | Active |
| Capsule Vitals Plus | CAP-VP-NIBPAH-MON-HW | FDA UDI | Class II | Active |
| Capsule Vitas Plus | CAP-VP-NIBPAH-MON-HW | FDA UDI | Class II | Active |
| Cab.2d Lo.noise Vcg, Phlps, 2, 7m | 452213160763 | FDA UDI | Class II | Unknown |
| Invivo | 459801572611 | FDA UDI | Class II | Active |
| Invivo | 45353035833 | FDA UDI | Class II | Active |
| SmartLinx Vitals Plus | SL-VP-BPAP-HW | FDA UDI | Class II | Active |
| Invivo | 45353025227 | FDA UDI | Class II | Active |
| Invivo | 45353027506 | FDA UDI | Class II | Active |
| Invivo | Lateral Grid, Lower dS Breast 16CH I/T | FDA UDI | Class II | 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 |
|---|---|---|---|---|
| May 1, 2026 | Z-2354-2026 | — | open, classified | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events. |
| Apr 14, 2026 | Z-1951-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1952-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1954-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1968-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1969-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1965-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1960-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1967-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1956-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1966-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1953-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1957-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1964-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1955-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1963-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1962-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1958-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1961-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Apr 14, 2026 | Z-1959-2026 | — | open, classified | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Jan 7, 2026 | Z-1317-2026 | — | open, classified | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled. |
| Jan 7, 2026 | Z-1318-2026 | — | open, classified | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled. |
| Jan 7, 2026 | Z-1316-2026 | — | open, classified | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled. |
| Jan 7, 2026 | Z-1315-2026 | — | open, classified | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled. |
| Dec 22, 2025 | Z-1156-2026 | — | open, classified | A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. |
| Dec 12, 2025 | Z-1033-2026 | — | open, classified | It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly. |
| Dec 3, 2025 | Z-1208-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1210-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1213-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1214-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1216-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1204-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1205-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1206-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1209-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1207-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1212-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1211-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Dec 3, 2025 | Z-1215-2026 | — | open, classified | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Oct 31, 2025 | Z-0864-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0852-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0858-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0849-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0868-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0859-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0851-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0863-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0867-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0865-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0855-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0866-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0869-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0870-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0853-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0854-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0861-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0860-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0856-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0857-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0862-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Z-0850-2026 | — | open, classified | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 29, 2025 | Z-0881-2026 | — | open, classified | If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger. |
| Oct 29, 2025 | Z-0882-2026 | — | open, classified | If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger. |
| Oct 27, 2025 | Z-0597-2026 | — | open, classified | Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications. |
| Sep 12, 2025 | Z-0166-2026 | — | open, classified | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| Sep 12, 2025 | Z-0165-2026 | — | open, classified | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| Aug 13, 2025 | Z-2599-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Z-2597-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Z-2595-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Z-2598-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Z-2603-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Z-2602-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Z-2596-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Z-2604-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Z-2601-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Z-2600-2025 | — | open, classified | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Jun 30, 2025 | Z-2213-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2215-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2208-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2216-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2218-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2211-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2201-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2200-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2217-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2204-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2210-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2209-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2202-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2205-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2207-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2203-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2206-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2214-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| Jun 30, 2025 | Z-2212-2025 | — | open, classified | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| May 29, 2025 | Z-2034-2025 | — | open, classified | Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance. |
| May 29, 2025 | Z-1935-2025 | — | open, classified | identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage. |
| May 29, 2025 | Z-1929-2025 | — | open, classified | identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage. |
| May 29, 2025 | Z-1928-2025 | — | open, classified | identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage. |
| May 29, 2025 | Z-1931-2025 | — | open, classified | identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage. |