BEUDAMED
    FDA Recall Terminated

    3D-I/III Ceiling Stand. Diagnostic x-ray tube mount

    Recall: Z-1205-06 · Initiated April 28, 2006

    Recall

    Recall Number
    Z-1205-06
    Event Number
    35395
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2006
    Posted
    July 6, 2006
    Terminated
    September 30, 2008
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    3D-I/III Ceiling Stand. Diagnostic x-ray tube mount

    Reason

    Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers.

    Action

    The recalling firm has issued a field correction per Update Instructions AX012/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees to install a protective cover and additional warning labels on the device, beginning 04/28/2006.

    Distribution

    The products were shipped nationwide to medical facilities.

    Quantity

    466 units