BEUDAMED
    FDA Recall Terminated

    Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.

    Recall: Z-1241-2008 · Initiated June 21, 2007

    Recall

    Recall Number
    Z-1241-2008
    Event Number
    46381
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 21, 2007
    Posted
    June 27, 2008
    Terminated
    August 4, 2008
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.

    Reason

    MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.

    Action

    On 6/21-26/2007, AGFA Healthcare notified, via telephone, the affected consignees of the situation. On 7/2/2007, affected consignees were sent, via registered mail, an "Urgent Medical Device Correction" letter instructing them to: a) remove the affected software DICOMstore 2.04.40.00 and replace it with the prior software version, DICOMstore 2.04.34.02; and b) review patient ECG reports to determine if any patients were actually affected and to notify the firm. AGFA Healthcare also provided a customer service contact number (877) 777-2432.

    Distribution

    Worldwide Distributution - USA, including states of AZ, CA, DC, FL, IL, IN, KY, MA, ME, MN, MS, OH, OK, OR, NH, PA, SC, TN, TX, WI, and country of Canada.

    Quantity

    43 units