FDA Device recall Z-1417-2017
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536…
- FDA Device
- Class I
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class I recall of HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536… by Philips North America, citing heartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1417-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-02-24 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips North America |
| Distribution | US |
Product
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Reason
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Identifiers
| code_info | Model# Serial Numbers M3535A US00100100 to US00602546 M3535ATZ US00100100 to…Model# Serial Numbers M3535A US00100100 to US00602546 M3535ATZ US00100100 to US00602546 M3536A US00100902 to US00602540 (M3536ATZ) US00100902 to US00602540 M3536M US00500002 to US00553553 M3536MC US00500001 to US00500087 M3536M2 US00554176 to US00554178 M3536M3 US00571854 to US00588995 M3536M4 US00500003 to US00590982 M3536M5 US00500001 to US00587771 M3536M6 US00554358 to US00600582 M3536M7 US00581047 to US00601962 M3536M8 US00590958 to US0059095 M3536M9 US00581048 to US00581049 |
|---|
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-1417-2017%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.