BEUDAMED
    FDA Recall Terminated

    IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database.

    Recall: Z-0945-2009 · Initiated December 24, 2008

    Recall

    Recall Number
    Z-0945-2009
    Event Number
    50755
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 24, 2008
    Posted
    February 3, 2009
    Terminated
    April 1, 2010
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database.

    Reason

    Polling procedure may fail when multiple merge/split is carried out.

    Action

    All sites potentially affected by this product were notified of the issue directly via telephone. Each site was directed to observe a ten minute polling window as an interim mitigation until the normal mitigation by software Service Update is performed at the site by Agfa Support. An Urgent Safety Notice was sent via FED-EX on/about 12/24/2008 to all sites. The letter describes the potential issue and both interim and formal mitigation. Acknowledgment, via FAX-Back, that the information was received and understood was requested from the sites.

    Distribution

    Nationwide Distribution --- including states of FL, IL, OR, SC, and SD.

    Quantity

    5 units