BEUDAMED
    FDA Recall Terminated

    FastPlan Treatment Planning System, Model HZ3, Varian Medical Systems, Palo Alto, CA. Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing tablet, and radiation treatment planning application software.

    Recall: Z-1217-2012 · Initiated January 30, 2012

    Recall

    Recall Number
    Z-1217-2012
    Event Number
    61193
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 30, 2012
    Posted
    March 16, 2012
    Terminated
    October 21, 2013
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    FastPlan Treatment Planning System, Model HZ3, Varian Medical Systems, Palo Alto, CA. Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing tablet, and radiation treatment planning application software.

    Reason

    An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects to "Discard" that slice, an incorrect calculation of the isocenter location may result.

    Action

    "Urgent Medical Device Correction/Urgent Field Safety Notification" letters were sent on January 30, 2012 by certified mail to consignees in the US and by Federal Express for Canada. International sites will be notified by Varian International Customer Support Managers, who will translate letters if necessary. The notice provided a description of the issue, the actions that can be taken to avoid or mitigate the issue, and the steps Varian is taking to address the issue. Customer service number for US and Canada is: (888) 827-4265.

    Distribution

    Worldwide Distribution - Nationwide (USA) and the countries of Canada, China, Germany, Ireland, Spain, Singapore, Georgia, Hong Kong, India, Macau, Malaysia, Russia, Sri Lanka, Taiwan, Japan, Chile, Columbia, Venezuela and Australia.

    Quantity

    201