HeartStart MRx — Class II medical device recall Z-0603-2019
Terminated recall by Philips North America LLC, reported 2018-12-19, distributed in AL, AR, AZ, CA, CO, FL, GA, IL…. Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the componen
| Recall number | Z-0603-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America LLC, Bothell, WA, United States |
| Recall initiated | 2018-11-23 |
| Classified | 2018-12-13 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-09-29 |
| Distributed | 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 |
| Countries outside the US | AR, AT, AU, BE, BO, BR, CA, CH, CL, CR, DE, EE, ES, FR, GB, IE, IN, IT, KR, LK, MX, NL, NZ, PT, QA, SA, SG, SI, TT, TW, ZA |
| Quantity | 1,880 batteries |
| UPC / GTIN / UDI-DI | 00884838002791 |
| Serial numbers | 17362-0001-P |
| Model numbers | M3538A |
Product
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0603-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.