FDA Device recall Z-2842-2016
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A by Philips Electronics North America, citing the handle can separate from the MRx housing due to breakage of mounts on the rear case.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2842-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-26 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Reason
The handle can separate from the MRx housing due to breakage of mounts on the rear case.
Identifiers
| code_info | US Serial Numbers: US00100227 US00100297 US00100326 US00100337 US00100429 US00100715 US00101184 US00101468 US0…US 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 US00207324 US00207345 US00208019 US00208263 US00208431 US00208519 US00210744 US00210966 US00211478 US00211485 US00212939 US00213455 US00213819 US00214103 US00214173 US00214222 US00316387 US00316389 US00316444 US00317530 US00318184 US00318460 US00321017 US00321936 US00323885 US00325280 US00326630 US00327632 US00328050 US00328154 US00328968 US00330028 US00330043 US00330093 US00331414 US00332111 US00534036 US00534522 US00535148 US00535803 US00539517 US00540460 US00541251 US00541256 US00541257 US00541366 US00541627 US00543683 US00543856 US00544956 US00545221 US00545649 US00554157 US00555242 US00571887 US00574441 US005747 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2842-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.