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Philips North America LLC

United States·US-MF-000033010

Last updated September 17, 2026

What Philips North America LLC makes

Philips North America LLC manufactures patient monitoring systems, including centralized monitors and software for clinical management. Their products integrate vital signs monitoring modules, such as the SmartLinx Vitals Plus and Capsule Vitals Plus, designed for real-time patient data aggregation and interfacing with hospital networks.

These devices are classified as Class II and Class IIb under regulatory frameworks, with listings in the EU’s eudamed database, FDA’s 510(k) clearance records, and FDA’s Unique Device Identifier (UDI) system. The company 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 medical devices does Philips North America LLC manufacture?

Philips North America LLC specializes in patient monitoring systems, including centralized patient monitors and clinical management support software. Their devices focus on interfacing modules like the SmartLinx Vitals Plus and Capsule Vitals Plus, which aggregate and display real-time patient vital signs for hospital environments. These products are designed to integrate with existing healthcare infrastructure, improving data accessibility and clinical workflows.

Where is Philips North America LLC based, and what regulatory regions do its devices operate in?

Philips North America LLC is headquartered in the United States. Its devices are authorized for use in both the EU and the US, as evidenced by listings in the EU’s eudamed database and the FDA’s 510(k) clearance records and Unique Device Identifier (UDI) system. This reflects compliance with regional regulatory requirements for medical devices.

How are Philips North America LLC’s devices classified under regulatory frameworks?

Philips North America LLC’s devices fall under Class II and Class IIb classifications, which are standard for moderate-risk medical devices requiring regulatory oversight. Class II devices typically involve special controls to ensure safety and effectiveness, while Class IIb devices may pose a higher risk due to sustained or frequent use, necessitating additional scrutiny during authorization.

Which regulatory registries list Philips North America LLC’s devices?

Philips North America LLC’s devices are documented in three key regulatory registries: the EU’s eudamed database (for EU-authorized products), the FDA’s 510(k) clearance records (for US pre-market submissions), and the FDA’s Unique Device Identifier (UDI) system (to track devices post-authorization). These listings ensure transparency and traceability of the devices’ regulatory status.

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

Information

Country: United States
Address: 3630, SW 47th Ave, Gainesville, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Kenneth Revennaugh
EUDAMED SRN: US-MF-000033010
FDA FEI Number: 3016618143
DUNS Number: 001291111

Catalogue (703)

Page 14 of 15

Device	Model / Reference	Registries	Class	Status
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
Expression MR KIT, WATER TRAP, ETCO2, 3160	Kit, Water Trap, EtCO2, 3160	FDA UDI	Class II	Unknown
Expression MRI Patient Monitoring System (Model 865214)	Expression MRI Patient Monitor	FDA UDI	Class II	Unknown
Invivo	45353032128	FDA UDI	Class II	Active
Invivo	106453	FDA UDI	Class II	Active
Expression MR400 MRI Patient Monitoring System (Model MR400)	Expression MR400 Accessories	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
Invivo	415GE-64A	FDA UDI	Class II	Active
SpO2 SENSOR GRIP ADULT/NEONATAL 2 PACK -989803162501	SPO2 Sensor Grip, Adult/Neonatal 2 pack	FDA UDI	Class II	Unknown
Invivo	109188	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-NIBPAH-MON-HW	FDA UDI	Class II	Active
Xper Flex Cardio Physiomonitoring System	Xper Flex Cardio 2010 Rev D Russia	FDA UDI	Class II	Unknown
SmartLinx Vitals Plus	SL-VP-NIBPAH-MON-HW	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
MR Patient Care Short Standard ECG 2.0 Cable AAMI	CAB,4 LD,CV MRI ECG	FDA UDI	Class II	Active
Invivo	98960320286	FDA UDI	Class II	Active
Invivo	SENSE Torso 8	FDA UDI	Class II	Active
Invivo	105963	FDA UDI	Class II	Active
Sentinelle	459801813441	FDA UDI	Class I	Active
Kit, Sample, Agents, 3160	Kit, Sample, Agents, 3160	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-NIBPAH-MON-HW	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
Invivo	98960320421	FDA UDI	U	Active
Invivo	106394	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
Invivo	784012	FDA UDI	Class II	Active
FiberTEMP Fiber Optic Surface Temperature Sensor	989803152801	FDA UDI	Class II	Unknown
SmartLinx Vitals Plus	SL-VP-NIBPAH-MON-HW	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
Cab, Ecg, 5 Ld, Unshld, 10ft, Safty	989803158501	FDA UDI	Class II	Active
Invivo	SENSE Spine 8	FDA UDI	Class II	Active
Invivo	Lateral Grid, Upper dS Breast 16CH I/T	FDA UDI	Class II	Active
Invivo	98960321018	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-NIBPAH-MON-HW	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
Quick Connect SpO2 Starter Kit	989803167111	FDA UDI	Class II	Active
Invivo	472GE-42	FDA UDI	Class II	Active
Invivo	98960320321	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
SmartLinx Vitals Plus	SL-VP-NIBPAH-MON-HW	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
Xper Flex Cardio Physiomonitoring System	FC2020	FDA UDI	Class II	Unknown
MR Patient Care NIBP Cuff Sample Kit (8 piece)	NiB Cuff, Single Lumen, Sample Kit,Disp)	FDA UDI	Class II	Unknown
SmartLinx Vitals Plus	SL-VP-BPAP-HW	FDA UDI	Class II	Active
Invivo	585TO-64	FDA UDI	Class II	Active
Invivo	4535-303-12931	FDA UDI	Class I	Unknown
Invivo	45353022871	FDA UDI	Class II	Active
Switched Internal Paddles	K203231	FDA 510(k)	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.

Philips North America LLC has 527 recall records initiated between February 24, 2017, and May 1, 2026. The records reflect various statuses, including completed, open, classified, and terminated. Reasons cited include potential component failures causing smoke or fire, incorrect labeling on medical devices, manufacturing defects such as broken parts or non-compliant assembly, missing certification labels, software malfunctions, and missing safety components like the Source-to-Skin Distance (SSD) spacer. Additional issues involve cooling system leaks, radiation dose increases, and incorrect warning labels.

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
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.