FDA Device recall Z-0608-2020
HeartStart XL+ Defibrillator/Monitor, Model 861290
- FDA Device
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of HeartStart XL+ Defibrillator/Monitor, Model 861290 by Philips North America, citing 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 sta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0608-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-03 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
HeartStart XL+ Defibrillator/Monitor, Model 861290
Reason
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.
Identifiers
| code_info | All Units, Model number 861290 |
|---|
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-0608-2020%22
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