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FDAMay 19, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

baxter healthcarebaxter

UPCs

00887761995086

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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