FDA Device recall Z-2347-2012
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536…
- FDA Device
- Class II
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class II recall of Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536… by Philips Healthcare, citing therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2347-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-20 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, 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
Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables
Identifiers
| code_info | Philips HeartStart MRx monitor/defibrillators manufactured prior to June 2012 and used in external transport and Emerge…Philips HeartStart MRx monitor/defibrillators manufactured prior to June 2012 and used in external transport and Emergency Medical Service (EMS) environments, distributed worldwide |
|---|
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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All Philips Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2347-2012%22
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