BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2006-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2006-2023
    Event ID
    92300
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2023
    Initiation Date
    May 19, 2023
    Classification Date
    June 26, 2023
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

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

    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 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

    Distribution

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

    Quantity

    8 software versions