Philips HeartStart MRx monitor/defibrillators Models: M3535A and… — Class II medical device recall Z-2347-2012
Terminated recall by Philips Healthcare Inc., reported 2012-09-19, distributed nationwide. Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Ca
| Recall number | Z-2347-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2012-06-20 |
| Classified | 2012-09-10 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2017-02-15 |
| 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, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SI, SV, TH, TN, TR, TT, TW, UA, VE, VN, ZA |
| Quantity | 58,701 units |
| Reason classes | device malfunction |
| Model numbers | M3535A, M3536A, M3536J, M3536M, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536MC |
Product
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, 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
Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables
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-2347-2012. 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.