Reported Dec 19, 2018 · Terminated
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America LLC · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- HeartStart MRx, Rechargeable Li-Ion (lithium ion battery)
- REFM3538A, which is a component of HeartStart MRx Monitor/Defibrillators
- Lot codes and dates
- UDI(01)00884838002791
- Serial Numbers17362-0001-P through 18057-0266-P
- Amount recalled
- 1880 Batteries
Where it was sold
Why it was recalled
Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.
This product could cause temporary or reversible health problems — stop using it.
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