HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A — Class II medical device recall Z-2842-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-09-28, distributed nationwide. The handle can separate from the MRx housing due to breakage of mounts on the rear case.
| Recall number | Z-2842-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-08-26 |
| Classified | 2016-09-19 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2020-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, ES, FR, GB, IN, JP, NL, SE, TH, ZA |
| Quantity | 394 units |
| Reason classes | device malfunction |
| Serial numbers | US00100227, US00100297, US00100326, US00100337, US00100429, US00100715, US00101184, US00101468, US00101676, US00101690, US00102018, US00203809, US00205745, US00205756, US00206142, US00206498, US00206615, US00206821, US00207095, US00207101, US00207144, US00207209, US00207268, US00207295, US00207321 and 57 more |
| Model numbers | M3535A, M3536A |
Product
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Reason for recall
The handle can separate from the MRx housing due to breakage of mounts on the rear case.
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-2842-2016. 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.