FDA-Device2023-07-05Class II
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Baxter Healthcare Corporation
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.
Sold states
US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
Affected count
8 software versions
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2006-2023Don't want to check this manually?
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