BEUDAMED
    FDA Enforcement Class II Terminated

    Cios care fusion system

    Recall: Z-1954-2019 · Reported July 17, 2019

    Enforcement

    Recall Number
    Z-1954-2019
    Event ID
    83255
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2019
    Initiation Date
    June 20, 2019
    Classification Date
    July 9, 2019
    Termination Date
    April 17, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Cios care fusion system

    Reason

    DAP chamber may be missing an insulating foil

    Code Info

    material # 10308192 Serial # 31375

    Distribution

    IL, NE

    Quantity

    1