BEUDAMED
    FDA Recall Terminated

    Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.

    Recall: Z-0056-2008 · Initiated August 24, 2007

    Recall

    Recall Number
    Z-0056-2008
    Event Number
    39408
    Firm
    Mallinckrodt Inc
    FEI Number
    1518293
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 24, 2007
    Posted
    October 13, 2007
    Terminated
    August 17, 2010
    Address
    2111 E Galbraith Rd, Cincinnati, OH, 45237-1624

    Description

    Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.

    Reason

    Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv

    Action

    On 9/20/2007, a notification was sent from Mallinckrodt to all direct accounts via certified mail. The notification details the potential for mis-synchronization of injection parameters if the main and auxiliary consoles are simultaneously programmed. The notification reminds end-users that simultaneous programming should not be performed and to ensure it is not performed, a notification label (provided in the notification) is to be affixed on both consoles of the injector system. Once the label is affixed to the system, end-users are instructed to complete the notification survey and return the survey to the Mallinckrodt. In addition, the notification includes an updated chapter insert (Chapter 11.1) for the injector system's product manual that emphasize the separation between programming of the main and auxiliary consoles. Questions regarding this matter may be directed to Mallinckrodt's Product Monitoring Department at 1-888-744-1414, menu option 1 and then menu option 2.

    Distribution

    Worldwide to include:U.S.A. states of - AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, & WI. and Foreign countries of Argentina, Belgium, Brazil, Canada, Germany, Japan, Singapore, & Zambia.

    Quantity

    176