HeartStart XL+ Defibrillator/Monitor — Class II medical device recall Z-0498-2020
Terminated recall by Philips North America, LLC, reported 2019-11-27, distributed nationwide. The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include:
| Recall number | Z-0498-2020 |
|---|---|
| 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 | 2019-10-16 |
| Classified | 2019-11-19 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 23,749 units |
| Reason classes | device malfunction |
| Model numbers | 861290 |
Product
HeartStart XL+ Defibrillator/Monitor, Model 861290
Reason for recall
The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.
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-0498-2020. 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.