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

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL. Quantity: 8 software versions 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

UPC codes

00887761995086

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.