Philips HeartStart XL Defibrillator/Monitor — Class II medical device recall Z-2053-2020
Terminated recall by Philips North America, LLC, reported 2020-05-27, distributed nationwide. The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device
| Recall number | Z-2053-2020 |
|---|---|
| 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 | 2020-04-13 |
| Classified | 2020-05-20 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2021-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 94,034 units |
| Reason classes | device malfunction |
| Model numbers | M4735A |
Product
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital 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. It must be used by or on the order of a physician.
Reason for recall
The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
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-2053-2020. 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.