FDA Device recall Z-1194-2014
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the te…
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the te… by Philips Medical Systems, citing when the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1194-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-18 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 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
When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
Identifiers
| code_info | MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587 |
|---|
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-1194-2014%22
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