BEUDAMED
    FDA Recall Terminated

    Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7559375 Upper Body radiation shield, Artis T.

    Recall: Z-1439-2009 · Initiated May 1, 2009

    Recall

    Recall Number
    Z-1439-2009
    Event Number
    51947
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 1, 2009
    Posted
    June 16, 2009
    Terminated
    September 1, 2009
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7559375 Upper Body radiation shield, Artis T.

    Reason

    Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.

    Action

    The recalling firm has decided to inspect all of the installed units for this condition and where necessary replace the missing clip. The recalling firm has issued an Update Instructions AX011/09/S dated 03.09, which provides instructions on how to perform a visual inspection of the Mavig Portegra 2 arm for the presence of the safety clip and the installation instructions on how to properly install the clip if it is missing.

    Distribution

    Nationwide Distribution.

    Quantity

    427 units