BEUDAMED
    FDA Enforcement Class II Terminated

    3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.

    Recall: Z-2838-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2838-2018
    Event ID
    80735
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    June 29, 2018
    Classification Date
    August 17, 2018
    Termination Date
    October 4, 2019
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.

    Reason

    In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock and this could lead to overloading the safety rope which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down during patient positioning. Patients and users may be seriously injured.

    Code Info

    7042042 : S/N 1002 to 1787 7042059: S/N 1002 to 1921

    Distribution

    US Nationwide Distribution to accounts in IL, FL, and NY.

    Quantity

    667