BEUDAMED
    FDA Recall Terminated

    ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.

    Recall: Z-0352-06 · Initiated November 18, 2005

    Recall

    Recall Number
    Z-0352-06
    Event Number
    34087
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2005
    Posted
    January 6, 2006
    Terminated
    January 12, 2012
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.

    Reason

    Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.

    Action

    Consignees were notified by letter on/about December 1, 2005.

    Distribution

    Nationwide

    Quantity

    1059 units