FDA Device recall Z-2006-2023
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed by Baxter Healthcare, citing baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2006-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-19 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Reason
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.
Identifiers
| code_info | UDI/DI 00887761995086, Software Versions: 4.0: 4.0.000, 4.0.100, 4.0.110, 4.0.200, 4.0.300, 4.0.301, 4.0.400, 4.0.401 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2006-2023%22
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