FDA Device recall Z-0613-2014
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx…
- FDA Device
- Class II
- terminated
- Published 2014-01-08
On 2014-01-08 the FDA classified a Class II recall of Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx… by Philips Medical Systems, citing device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0613-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-10 |
| Published | 2014-01-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 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
Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and
Identifiers
| code_info | Serial numbers ranging: From US00100100 to US00210461 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0613-2014%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.