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Oxygen concentrator may melt or catch on fire during use.

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Venue Go Models R2/R3 (GE Medical Systems) – Battery Fire Risk (2025)
Fire/Burn Risk
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
High
FDAMar 6, 2025Nationwide• GE Medical Systems, LLC
Zebra Thermal Printer (Remel) – fire hazard (2025)
Fire/Burn Risk
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
High
FDAFeb 12, 2025AL, AZ, CA +14 more• Remel, Inc

Kinova Inc: KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001,...
Fire/Burn Risk
Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.
High
FDAAug 22, 2024Nationwide• Kinova Inc

Siemens Medical Solutions USA, Inc: AXIOM MULTIX MP - Inended Radiographic X ray Table is a p...
Fire/Burn Risk
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
High
FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: AXIOM MULTIX MP - Intended Radiographic X ray Table is a ...
Fire/Burn Risk
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
High
FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: AXIOM Vertix MD - The Vertix MD Trauma has been specially...
Fire/Burn Risk
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
High
FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a...
Fire/Burn Risk
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
High
FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: AXIOM MULTIX MT - Intended Radiographic X ray Table is a ...
Fire/Burn Risk
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
High
FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: AXIOM Vertix Solitaire - The Vertix MD Trauma has been sp...
Fire/Burn Risk
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
High
FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: MULTIX TOP - Intended Use: The Multix TOP I PRO Radiograp...
Fire/Burn Risk
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
High
FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Canon Medical System, USA, INC.: MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage ...
Fire/Burn Risk
The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
High
FDAMay 10, 2024AL, AZ, AR +35 more• Canon Medical System, USA, INC.

LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany: Leica HistoCore Arcadia H, REF: 14039354100 and 140393572...
Fire/Burn Risk
An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
High
FDAMay 10, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

Philips North America Llc: MR RT - Magnetic Resonance (MR) systems are Medical Elect...
Fire/Burn Risk
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
High
FDAMay 3, 2024Nationwide• Philips North America Llc

Philips North America Llc: MR system 1.5T Marlin- Magnetic Resonance (MR) systems a...
Fire/Burn Risk
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
High
FDAMay 3, 2024Nationwide• Philips North America Llc

Philips North America Llc: Intera 1.5T- Magnetic Resonance (MR) systems are Medical ...
Fire/Burn Risk
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
High
FDAMay 3, 2024Nationwide• Philips North America Llc

Philips North America Llc: AchievaXR -Magnetic Resonance (MR) systems are Medical El...
Fire/Burn Risk
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
High
FDAMay 3, 2024Nationwide• Philips North America Llc

Philips North America Llc: Achieva 3.0T for PET -Magnetic Resonance (MR) systems are...
Fire/Burn Risk
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
High
FDAMay 3, 2024Nationwide• Philips North America Llc

Philips North America Llc: Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical...
Fire/Burn Risk
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
High
FDAMay 3, 2024Nationwide• Philips North America Llc

Philips North America Llc: Achieva 1.5T Conversion- Magnetic Resonance (MR) systems ...
Fire/Burn Risk
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
High
FDAMay 3, 2024Nationwide• Philips North America Llc