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FDA (Device enforcement)Recalled 2018-11-23closedclass ii

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

Is my product affected?

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

  • UPC 00884838002791

Check against the official notice below — it lists the full affected range.

What happened

Philips North America LLC is recalling 1,880 HeartStart MRx Rechargeable Lithium-Ion Batteries (model M3538A) distributed across the United States and multiple international locations. The batteries may contain a defective Thermal Cut-off component that could fail, preventing the battery from charging or delivering power to the Monitor/Defibrillator. If the device relies solely on the affected battery and is not connected to AC or DC power, it may not operate. The risk is heightened when a second, unaffected battery is present, as the failure of the defective battery could go undetected.

The affected batteries have serial numbers ranging from 17362-0001-P through 18057-0266-P and can be identified by UDI (01)00884838002791. The recall document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: U.S.: 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 Foreign (OUS): United Kingdom, Korea Rep, Singapore, Australia, Taiwan, Sri Lanka, Brazil, France, Switzerland, Germany, Austria, Spain, Italy, Trinidad and Tobago, Estonia, Belgium, Portugal, Korea, Republic of, Argentina, India, Puerto Rico, Qatar, Netherlands, Mex Quantity: 1880 Batteries Lot/code info: UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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