BEUDAMED
    FDA Recall Terminated

    Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891

    Recall: Z-1242-2008 · Initiated July 27, 2007

    Recall

    Recall Number
    Z-1242-2008
    Event Number
    46382
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 27, 2007
    Posted
    June 27, 2008
    Terminated
    October 10, 2008
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891

    Reason

    Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.

    Action

    On 7/27/2007 to 8/16/2007, AGFA Healthcare notified, via telephone, consignees of the situation. On 7/27/2007, a formal customer notification letter was sent to affected consignees, providing them with a respective listing of patients that were potentially affected. AGFA informed the consignees that the firm would correct any incorrect patient ECG data. AGFA also informed their consignees that they would provide a configuration update to correct the problem. A notification confirmation form to be return to the firm was also attached to the notification letter, which also provided the firm's customer service number: (877) 777-2432.

    Distribution

    Nationwide Distribution -- USA including states of GA, NH, NY and TX

    Quantity

    6 units