BEUDAMED
    FDA Recall Terminated

    AVE 2 Birthing Bed

    Recall: Z-0991-2019 · Initiated January 7, 2019

    Recall

    Recall Number
    Z-0991-2019
    Event Number
    81927
    Firm
    Linet Spol. S.r.o. Zelevcice 5 Slany Czech Republic
    FEI Number
    3008058231
    Product Code
    HDD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 7, 2019
    Terminated
    May 31, 2023

    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.

    Action

    The firm disseminated their urgent correction notices on 01/07/2019 by mail. The notice discussed the potential safety issue and requested the consignee cease use of the bed if there was damage to the power cable. The firm will be providing a kit that includes a power cable hook and updated instruction for use.

    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