FDA Device recall Z-1923-2019
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5,…
- FDA Device
- Class II
- terminated
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class II recall of Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5,… by Philips North America, citing the AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Inter….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1923-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-07 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Reason
The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.
Identifiers
| code_info | Serial numbers: US00321116 US00205647 US00205648 US00554104 US00554105 US00554106 US00559530 US00559531 US00559…Serial numbers: US00321116 US00205647 US00205648 US00554104 US00554105 US00554106 US00559530 US00559531 US00559532 US00559533 US00559534 US00559535 US00559536 US00559537 US00559538 US00559539 US00321076 US00321222 US00322701 US00544495 US00320900 US00580288 US00580298 US00580334 US00580335 US00580336 US00580337 US00580338 US00582916 US00582917 US00582918 US00582919 US00582920 US00582921 US00582922 US00582923 US00582924 US00582925 US00582926 US00582927 US00582928 US00582929 US00582930 US00582931 US00582932 US00582933 US00582934 US00582935 US00582936 US00582937 US00582938 US00582939 US00582940 US00582941 US00582942 US00582943 US00582944 US00582945 US00582946 US00582947 US00582948 US00582949 US00582950 US00582951 US00582952 US00582953 US00582954 US00582955 US00582956 US00582957 US00582958 US00582959 US00582960 US00582961 US00582962 US00582963 US00582964 US00582965 US00582966 US00582967 US00582968 US00582969 |
|---|
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-1923-2019%22
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