FDA Device recall Z-1189-2013
HeartStart MRx Monitor/Defribillator
- FDA Device
- Class II
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class II recall of HeartStart MRx Monitor/Defribillator by Philips Healthcare, citing device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1189-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-08 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Reason
Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.
Identifiers
| code_info | Serial numbers ranging from US00100100 to US00565942 Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2022-03-30 · Philips Healthcare - CombiDiagnost R90 is multi-functional general R/F systems
FDA Device · Class II · 2021-12-01 · Philips Healthcare - Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Device · Class II · 2021-12-01 · Philips Healthcare
All Philips Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1189-2013%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.