BEUDAMED
    FDA Recall Terminated

    Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.

    Recall: Z-0591-2012 · Initiated December 6, 2011

    Recall

    Recall Number
    Z-0591-2012
    Event Number
    60625
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 6, 2011
    Posted
    January 11, 2012
    Terminated
    April 11, 2012
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.

    Reason

    Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle.

    Action

    Agfa HealthCare sent a 'URGENT SAFETY NOTICE" letter dated December 6, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Agfa Service will contact your facility and schedule a software upgrade if this has not already been performed. Please complete the attached feedback form as soon as possible and fax it to 864-421-1662. If you have any questions about this matter, please contact your local Agfa HealthCare Service at 877-777-2432.

    Distribution

    Worldwide Distribution-- USA (nationwide) including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KS, LA, ME, MI, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, and Canada.

    Quantity

    125