FDA Device recall Z-1120-2014
HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricul…
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricul… by Philips Medical Systems, citing philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interfer….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1120-2014 |
| 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 Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J 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
Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source
Identifiers
| code_info | Serial numbers: 11327-0019-P 11315-0023-P 11315-0027-P 11315-0031-P 11315-0032-P 11315-0033-P 11315-0036-P…Serial numbers: 11327-0019-P 11315-0023-P 11315-0027-P 11315-0031-P 11315-0032-P 11315-0033-P 11315-0036-P 11315-0109-P 11315-0214-P 11315-0219-P 11315-0391-P 11322-0084-P 11322-0088-P 11327-0043-P 11327-0044-P Or within the following range: 11335-xxxx-P to 13214-xxxx-P |
|---|
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-1120-2014%22
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