BEUDAMED
    FDA Enforcement Class II Terminated

    AVE 2 Birthing Bed

    Recall: Z-0991-2019 · Reported March 20, 2019

    Enforcement

    Recall Number
    Z-0991-2019
    Event ID
    81927
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Linet Spol. S.r.o.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2019
    Initiation Date
    January 7, 2019
    Classification Date
    March 8, 2019
    Termination Date
    May 31, 2023
    Address
    Zelevcice 5, N/A, Slany, N/A, N/A, Czech Republic

    Description

    AVE 2 Birthing Bed

    Reason

    LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.

    Code Info

    Serial Numbers 4PPB0091 through 4PPB626

    Distribution

    AL, OK, NJ, OR, WA, CA, MN, LA, AZ, IL, MO, CO, OH, KY, FL, KS, UT, TN, LA, DE, CT, TX

    Quantity

    253 devices