FDA Device recall Z-1090-2014
HeartStart MRx Monitor/Defibrillator
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of HeartStart MRx Monitor/Defibrillator by Philips Medical Systems, citing A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to per….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1090-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-18 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC 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
A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform.
Identifiers
| code_info | Model M3535A: US00100100 to US00541372 Model M3536A: US00100902 to US00541375 Model M3536J: US00209838 to US00332675 Model M3536MC: US00500001 to US00500020 |
|---|
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-1090-2014%22
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