BEUDAMED
    FDA Recall Terminated

    Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX

    Recall: Z-1249-2011 · Initiated June 23, 2010

    Recall

    Recall Number
    Z-1249-2011
    Event Number
    56182
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 23, 2010
    Posted
    February 15, 2011
    Terminated
    May 3, 2011
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX

    Reason

    Position errors may result in misdelivery of radiation.

    Action

    Varian sent Urgent Medical Device Correction letters on June 23, 2010 by Federal Express to all customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** Field Safety notification including customer distribution lists, was e-mailed to Varian international Customer Support Managers. Managers will translate to local language if necessary, notify sites by appropriate methods.

    Distribution

    Worldwide distribution.

    Quantity

    5741 units