BEUDAMED
    FDA Recall Terminated

    IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.

    Recall: Z-1306-2008 · Initiated December 11, 2007

    Recall

    Recall Number
    Z-1306-2008
    Event Number
    46812
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LMD
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    December 11, 2007
    Posted
    July 1, 2008
    Terminated
    July 21, 2010
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.

    Reason

    Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.

    Action

    On 12/11/07, AGFA Healthcare sent out an e-mail to all affected consignees informing them of the situation. The firm also arranged to install the corrected License Key on all affected units of the product.

    Distribution

    Nationwide Distribution - USA, including states of CA, GA, IA and SD.

    Quantity

    12 units