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Showing 101–120 of 136 results

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Philips North America Llc: Achieva 1.5T

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Philips North America Llc: Intera 1.5T

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Steris Corporation: Reliance Vision Multi-Chamber Washer/Disinfector, Referen...

Fire/Burn Risk

In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

High

FDAApr 10, 2023Nationwide• Steris Corporation

Ellex Medical Pty Ltd.: Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integ...

When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.

FDAMar 16, 2023Nationwide• Ellex Medical Pty Ltd.

Abbott Diabetes Care, Inc.: FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01...

Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.

FDAFeb 13, 2023Nationwide• Abbott Diabetes Care, Inc.

Abbott Diabetes Care, Inc.: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01...

Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.

FDAFeb 13, 2023Nationwide• Abbott Diabetes Care, Inc.

Philips North America Llc: Philips Upgrade to MR 7700 System, Model Number 782130

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

FDANov 22, 2022Nationwide• Philips North America Llc

Philips North America Llc: Philips Ingenia Elition S MR System, Model Numbers 781357...

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

FDANov 22, 2022Nationwide• Philips North America Llc

Philips North America Llc: Philips SmartPath to Ingenia Elition X MR System, Model N...

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

FDANov 22, 2022Nationwide• Philips North America Llc

Philips North America Llc: Philips Ingenia Elition X MR System, Model Numbers 781358...

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

FDANov 22, 2022Nationwide• Philips North America Llc

Philips North America Llc: Philips MR 7700 System, Model Number 782120

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

FDANov 22, 2022Nationwide• Philips North America Llc

GE Medical Systems, LLC: Vivid S6 ultrasound. Used in ultrasound imaging and an...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Vivid i N ultrasound. Not marketed in the US. Used in u...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Vivid i ultrasound. Marketed under the following 510(k) ...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Vivid S6 N ultrasound. Not marketed in the US. Used in ...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Vivid q ultrasound. Used in ultrasound imaging and ana...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Vivid S5 Ultrasound. Used in ultrasound imaging and an...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Vivid S5 N ultrasound. Not marketed in the US. Used in ...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Vivid q N ultrasound. Not marketed in the US. Used in...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Ferno-Washington Inc: FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 001907...

Batteries could become unstable when not properly maintained and/or subjected to repeated drops, power washing directly into battery contacts or abuse, may result in a fire and/or injury

FDAOct 7, 2022Nationwide• Ferno-Washington Inc

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