BEUDAMED
    FDA Recall Terminated

    Atakr II RF Power Generator, Models 4802 and 4803

    Recall: Z-0618-03 · Initiated November 25, 2002

    Recall

    Recall Number
    Z-0618-03
    Event Number
    25111
    FEI Number
    2182208
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 25, 2002
    Posted
    March 6, 2003
    Terminated
    November 4, 2003
    Address
    7000 Central Ave N.E., Medtronic, Inc/Rice Creek Facil, Fridley, MN, 55432

    Description

    Atakr II RF Power Generator, Models 4802 and 4803

    Reason

    An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.

    Action

    An "Important Product Management Information" letter dated November 25, 2002 was sent to the affected consignees (hospitals) and it recommended certain actions to avoid the problem and stated that a software revision, (version 1.36) had been developed to eliminate the problem.

    Quantity

    775 units