BEUDAMED
    FDA Recall Terminated

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    Recall: Z-1069-2013 · Initiated March 15, 2013

    Recall

    Recall Number
    Z-1069-2013
    Event Number
    64654
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 15, 2013
    Posted
    April 8, 2013
    Terminated
    April 1, 2014
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    Reason

    Software design error in IMPAX CV 7.8 SU3

    Action

    AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to distribute this information within your facility to all individuals who need to be aware of this. Please fax back to (864) 421-1664 that the information was received and understood was requested from the customers. If you have any questions about this matter please contact your local AGFA Healthcare organization, or call (864) 421-1754.

    Distribution

    Distribute in the state of FL and KY

    Quantity

    2