BEUDAMED
    FDA Recall Terminated

    IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8

    Recall: Z-1676-2011 · Initiated February 10, 2011

    Recall

    Recall Number
    Z-1676-2011
    Event Number
    57932
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 10, 2011
    Posted
    March 16, 2011
    Terminated
    September 15, 2011
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8

    Reason

    A discrepancy in the validation testing which resulted in the product not performing as intended.

    Action

    AGFA sent an "URGENT SAFETY NOTICE" letter dated 2/10/11 via FED-EX to the customer. The letter included an acknowledgment which was to be FAX-Back indicating that the information was received and understood. Agfa has discussed with the customer how the de-installation of their CRS Remote product - Software Version 7.8_HL would be performed.

    Distribution

    TX

    Quantity

    One