medical Class II Updated 2023-07-05

Baxter Healthcare Corporation recalls Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401,

Recalled Product

Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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
View official government recall

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