FDA Device recall Z-2794-2020
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M353…
- FDA Device
- Class II
- terminated
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class II recall of Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M353… by Philips North America, citing the therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2794-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-16 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | n/a |
Product
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.
Reason
The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
Identifiers
| code_info | All devices are affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2794-2020%22
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