FDA recall Z-2006-2023

Baxter Healthcare Corporation · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2023-05-19
Report date
2023-07-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2006-2023