FDA Device recall Z-0732-2024
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
- FDA Device
- Class II
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 by Philips North America, citing push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0732-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-28 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Reason
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
Identifiers
| code_info | UDI-DI: 00884838099128 Software: CareEvent Version C.03.X |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0732-2024%22
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