BEUDAMED
    FDA Recall Terminated

    Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems

    Recall: Z-0213-2008 · Initiated June 25, 2007

    Recall

    Recall Number
    Z-0213-2008
    Event Number
    38376
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    KPQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 25, 2007
    Posted
    November 8, 2007
    Terminated
    February 4, 2008
    Address
    911 Hansen Way, Palo Alto, CA, 94304

    Description

    Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems

    Reason

    Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.

    Action

    The firm issued an Urgent Medical Device Correction letter to its customers by mail on June 25, 2007. It informed consignees of the anomaly in the software and workarounds for the issue. In addition, the firm also stated that they are currently validating a new software modification to repair the problem.

    Distribution

    Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.---

    Quantity

    14 units