BEUDAMED
    FDA Recall Terminated

    CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)

    Recall: Z-0353-06 · Initiated November 18, 2005

    Recall

    Recall Number
    Z-0353-06
    Event Number
    34088
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2005
    Posted
    January 6, 2006
    Terminated
    June 30, 2009
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)

    Reason

    Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.

    Action

    Consignees will be notified by letter on/about December 1, 2005 and offered upgraded software.

    Distribution

    Nationwide

    Quantity

    2630 units