BEUDAMED
    FDA Recall Terminated

    medical device and software systems

    Recall: Z-1314-04 · Initiated June 24, 2004

    Recall

    Recall Number
    Z-1314-04
    Event Number
    29471
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 24, 2004
    Posted
    August 7, 2004
    Terminated
    December 23, 2004
    Address
    3100 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    medical device and software systems

    Reason

    a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.

    Action

    Notification letter to consignees sent 06/14/2004.

    Distribution

    produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign

    Quantity

    28 units