Philips HeartStart MRx devices in use with the M3539A AC Power… — Class II medical device recall Z-1923-2019
Terminated recall by Philips North America, LLC, reported 2019-07-17, distributed nationwide. The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly instal
| Recall number | Z-1923-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2019-06-07 |
| Classified | 2019-07-05 |
| Reported by FDA | 2019-07-17 |
| Terminated | 2020-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 97,794 units |
| Reason classes | device malfunction |
| Serial numbers | US00, US00100181, US00100254, US00100595, US00100927, US00100928, US00100929, US00101297, US00101623, US00101691, US00101825, US00102134, US00102236, US00102513, US00102627, US00102692, US00203114, US00203115, US00203116, US00203117, US00203118, US00203119, US00203120, US00203121, US00203122 and 475 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1923-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.