BEUDAMED
    FDA Recall Terminated

    Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.

    Recall: Z-0892-2011 · Initiated January 19, 2010

    Recall

    Recall Number
    Z-0892-2011
    Event Number
    56350
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 19, 2010
    Posted
    January 11, 2011
    Terminated
    February 24, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.

    Reason

    There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly.

    Action

    Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail receipt on January 19, 2010, to all direct consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to have maintenance personnel perform the recommended measurements as described in the Varian Customer Technical Bulletin. Ensure that all measurements made as part of the procedure are recorded in the 'wear table' that is part of the procedure. Previous wear measurements should be compared to new measurements and any large increase in wear should be investigated immediately. Pay special attention to the "Recommendations based on wear measurements" table. Ensure that new wear measurements comply with the operating parameters described in the table. For any questions consignees are to contact Varian Medical Systems Customer Support Services at one of the locations described in the CTB. For questions regarding this recall call (650) 424-5731.

    Distribution

    Worldwide Distribution including USA, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada.