FDA Device recall Z-0603-2019
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators by Philips North America, citing 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 Mon….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0603-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-23 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips North America |
| Distribution | AL, AR, AZ, CA, CO, FL, GA, IL, KS, KY, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY |
Product
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
Reason
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.
Identifiers
| code_info | UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0603-2019%22
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