BEUDAMED
    FDA Recall Terminated

    High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.

    Recall: Z-0198-06 · Initiated September 21, 2005

    Recall

    Recall Number
    Z-0198-06
    Event Number
    33694
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 21, 2005
    Posted
    November 24, 2005
    Terminated
    July 12, 2007
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.

    Reason

    It was found during a study, arcing might occur in the transformer of the high voltage generator, XTP-8100G and XTBP-8100G displaying an error message and interrupting fluoroscopy.

    Action

    Consignees notification that a local TAMS service representative will schedule the implementation of the replacement transformer.

    Distribution

    CA, CO, KS, IL, LA, IN, ME, MI, NC, NJ, NY, OH, PA, TX

    Quantity

    30