BEUDAMED
    FDA Recall Terminated

    3D TOP Ceiling Stand. X-Ray System model number 8773673

    Recall: Z-0335-06 · Initiated November 30, 2005

    Recall

    Recall Number
    Z-0335-06
    Event Number
    34191
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 30, 2005
    Posted
    December 31, 2005
    Terminated
    July 19, 2006
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    3D TOP Ceiling Stand. X-Ray System model number 8773673

    Reason

    screws on the rollers may become loose

    Action

    The recalling firm has issued a field correction per Update Instructions AX004/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees and checkthe screws on the rollers. It also provides roller bearing sleeves as a secondary safety mechanism to prevent the rollers from detaching.

    Distribution

    The products were shipped to hospitals and medical facilities nationwide.

    Quantity

    460 units