FDA Device recall Z-0498-2020
HeartStart XL+ Defibrillator/Monitor, Model 861290
- FDA Device
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of HeartStart XL+ Defibrillator/Monitor, Model 861290 by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0498-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-16 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
HeartStart XL+ Defibrillator/Monitor, Model 861290
Reason
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.
Identifiers
| code_info | All units manufactured prior to 1 May 2017. |
|---|
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-0498-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.