BEUDAMED
    FDA Recall Terminated

    IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

    Recall: Z-0033-2007 · Initiated August 8, 2006

    Recall

    Recall Number
    Z-0033-2007
    Event Number
    36203
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 8, 2006
    Posted
    October 12, 2006
    Terminated
    February 20, 2007
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

    Reason

    Failed CAD displayed as 'No Findings'

    Action

    Consignees were notified by letter on/about 08/08/2006.

    Distribution

    Nationwide.

    Quantity

    20 Impax 5.2 Mammo licenses were issued domestically.