BEUDAMED
    FDA Recall Terminated

    Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX

    Recall: Z-0154-06 · Initiated October 10, 2005

    Recall

    Recall Number
    Z-0154-06
    Event Number
    33846
    Firm
    Medrad Inc
    FEI Number
    2520313
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 10, 2005
    Posted
    November 16, 2005
    Terminated
    August 15, 2007
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759

    Description

    Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX

    Reason

    the heat maintainer, an accessory, may overheat and deform the disposable syringe

    Action

    The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/12/05 via certified mail. The notice provided instructions to apply warning labels and disconnect the heat maintainer until a field upgrade kit is available. In case where the heat maintainer is a necessity for specific procedures, the customer is being instructed to observe certain precautions.

    Distribution

    The products were shipped to medical facilities nationwide. The products were also shipped to Canada, Isreal, Italy, Denmark, Netherlands, Norway, Great Britain, France, Poland, Germany, Spain, Finland, Belgium, Sweden, Russia, Austraila, Cuba, Mexico, Peru, Hong Kong, Korea, Mylasia, Thialand, Taiwan, Singapore, India, China, Turkey, Saudia Arabia, and Japan

    Quantity

    4362 units