FDA Device recall Z-0320-2016
Philips HeartStart MRx Monitor/Defibrillator
- FDA Device
- Class II
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class II recall of Philips HeartStart MRx Monitor/Defibrillator by Philips Electronics North America, citing the following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the au….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0320-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-14 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
Reason
The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off.
Identifiers
| code_info | Devices manufactured prior to June 4, 2015. Affected serial numbers range from US00100100 - US00587045. |
|---|
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-0320-2016%22
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