HeartStart XL+ Defibrillator/Monitor — Class II medical device recall Z-0608-2020
Terminated recall by Philips North America, LLC, reported 2019-12-11, distributed nationwide. Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for us
| Recall number | Z-0608-2020 |
|---|---|
| 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 | 2019-10-03 |
| Classified | 2019-12-05 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 24,738 units |
| Reason classes | device malfunction |
| Model numbers | 861290 |
Product
HeartStart XL+ Defibrillator/Monitor, Model 861290
Reason for recall
Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.
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-0608-2020. 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.