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Recall Observatory FDA recall evidence

Device product

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

Z-2006-2023

May 19, 2023

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 92300
Status
Ongoing
Classification
Class II
Quantity
8 software versions
Official record key
device-enforcement:Z-2006-2023

Official wording

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.

Code information: 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

Distribution pattern: US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.