BEUDAMED
    FDA Recall Terminated

    3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 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-2837-2018 · Initiated June 29, 2018

    Recall

    Recall Number
    Z-2837-2018
    Event Number
    80735
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 29, 2018
    Terminated
    October 4, 2019
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 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.

    Action

    On 6/29/18, the firm emailed its four affected original equipment manufacturers (OEMs), alerting them to the potential malfunction of the ceiling stand's lifting column that could cause the arm to drop down during patient positioning. Manufacturers were asked to distribute an attached Safety Notice to affected customers. In addition, the firm urged manufacturers to order retrofit kits for all customers and to take any steps needed to ensure that customers install the kits. The kits are free of charge. Manufacturers were also asked to complete a response form and return to the firm. Affected customers were advised of the product problem and instructed to install retrofit kits to avoid risk to patients and to users. If you have any questions, please contact Mr. Wolfgang Bohrer at [email protected].

    Distribution

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

    Quantity

    699