BEUDAMED
    FDA Recall Terminated

    Cios care fusion system

    Recall: Z-1954-2019 · Initiated June 20, 2019

    Recall

    Recall Number
    Z-1954-2019
    Event Number
    83255
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 20, 2019
    Terminated
    April 17, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Cios care fusion system

    Reason

    DAP chamber may be missing an insulating foil

    Action

    1. Siemens will inspect the DAP chamber on your unit, and if necessary, replace it with insulated DAP chamber. 2. Siemens service organization will contact you shortly to arrange a date to perform this corrective action. 3. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.

    Distribution

    IL, NE

    Quantity

    1