HeartStart MRx Monitor/Defibrillator — Class II medical device recall Z-0963-2015
Terminated recall by Philips Medical Systems, Inc., reported 2015-01-21, distributed nationwide. Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
| Recall number | Z-0963-2015 |
|---|---|
| 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 | 2014-11-19 |
| Classified | 2015-01-13 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2019-10-04 |
| Distributed | Nationwide (US) |
| Quantity | 74,499 devices |
| Reason classes | device malfunction |
| Model numbers | M3535A, M3536A, M3536J, M3536M, M3536M2, M3536M4, M3536M5, M3536M6, M3536MC, US00100100, US00100902, US00209838, US00332675, US00500001, US00500002, US00500003, US00500087, US00553553, US00554176, US00554178, US00554358, US00562935, US00574869, US00576619, US00576623 and 1 more |
Product
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: 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 may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
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-0963-2015. 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.