HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries… — Class II medical device recall Z-1120-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-03-05, distributed nationwide. Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpect
| Recall number | Z-1120-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-02-18 |
| Classified | 2014-02-26 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2020-09-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BD, BH, BO, BR, CA, CH, CN, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, HK, HR, ID, IE, IL, IN, IS, IT, JO, JP, KE, KR, KW, LB, LT, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, SE, SG, SI, SV, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 43,792 batteries |
| Serial numbers | 11315-0023-P, 11315-0027-P, 11315-0031-P, 11315-0032-P, 11315-0033-P, 11315-0036-P, 11315-0109-P, 11315-0214-P, 11315-0219-P, 11315-0391-P, 11322-0084-P, 11322-0088-P, 11327-0019-P, 11327-0043-P, 11327-0044-P |
Product
HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Reason for recall
Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source
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-1120-2014. 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.