medical Class II Updated 2018-12-19

Philips North America LLC recalls HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), R

Recalled Product

HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.

Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, WA, PA, UT, NY, CO, MD, AR, TX, MO, MI, FL, VA, MA, GA, TN, NV, OH, CA, NH, KY, KS, OR, WI, NC, IL, LA, NJ, WV, AL, WY, MS
Lot/Code Info: UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P
View official government recall

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