Philips HeartStart MRx Monitor/Defibrillator Models: M3536A — Class II medical device recall Z-0613-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-01-08, distributed nationwide. Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagneti
| Recall number | Z-0613-2014 |
|---|---|
| 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 | 2013-04-10 |
| Classified | 2013-12-31 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2017-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, TT, TW, UA, VE, VN, ZA |
| Quantity | 64,972 |
| Model numbers | M3536A, M3536J, M3536M, M3536M2, M3536M4, M3536M5, M3536M6, M3536MC |
Product
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 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
Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and
Machine access
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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.