BEUDAMED
    FDA Recall Terminated

    Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Primary users are radiologists, mammographers, orthopaedists and other trained medical staff.

    Recall: Z-1887-2009 · Initiated July 16, 2009

    Recall

    Recall Number
    Z-1887-2009
    Event Number
    52757
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 16, 2009
    Posted
    September 8, 2009
    Terminated
    April 28, 2011
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Primary users are radiologists, mammographers, orthopaedists and other trained medical staff.

    Reason

    Measurements are inaccurate on multiple workstations.

    Action

    Agfa Healthcare issued an "URGENT FIELD SAFETY NOTICE" dated July 16, 2009. The notice informed of the problem and provided details to identify potentially compromised data that could result in measurement inaccuracies. A feedback form was provided to be completed and returned to the firm. For further information, contact Agfa Healthcare at 1-773-592-4769.

    Distribution

    Nationwide Distribution -- IL

    Quantity

    One unit