BEUDAMED
    FDA Enforcement Class I Ongoing

    Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901

    Recall: Z-0145-2023 · Reported November 9, 2022

    Enforcement

    Recall Number
    Z-0145-2023
    Event ID
    90865
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 9, 2022
    Initiation Date
    September 30, 2022
    Classification Date
    October 31, 2022
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901

    Reason

    Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

    Code Info

    UDI/DI 00887761998865, all serial numbers

    Distribution

    US

    Quantity

    129 units