Philips HeartStart MRx Monitor/Defibrillator — Class II medical device recall Z-1118-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-03-05, distributed nationwide. ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in
| Recall number | Z-1118-2014 |
|---|---|
| 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 | 2018-02-20 |
| 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, 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, QA, RO, SA, SE, SG, SI, TH, TN, TR, TT, TW, UA, VE, VN, ZA |
| Quantity | 49,929 units |
| Model numbers | M3535A, M3536A, M3536J, M3536M, M3536M5, M3536MC |
Product
Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.
Reason for recall
ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal
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-1118-2014. 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.