Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A — Class II medical device recall Z-1155-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-03-19, distributed nationwide. MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a
| Recall number | Z-1155-2014 |
|---|---|
| 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 | 2014-03-07 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2020-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BH, BR, CA, CH, CN, DE, EE, EG, ES, FI, FR, GB, GH, ID, IE, IL, IN, IS, IT, JO, JP, KE, KR, LB, LT, LV, MX, MY, NL, NO, NZ, PE, PK, PL, PT, QA, SA, SE, SG, TH, TW, VN, ZA |
| Quantity | 3,541 units |
| Model numbers | 861288, 861289, 861464, 861483, 861491, M3535A, M3536A, M3536M, M3536M4, M3536M6 |
Product
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Reason for recall
MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing
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-1155-2014. 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.