BEUDAMED
    FDA Recall Terminated

    Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304

    Recall: Z-0554-2008 · Initiated September 26, 2007

    Recall

    Recall Number
    Z-0554-2008
    Event Number
    45519
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 26, 2007
    Posted
    January 29, 2008
    Terminated
    September 30, 2009
    Address
    911 Hansen Way, Palo Alto, CA, 94304

    Description

    Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304

    Reason

    Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered

    Action

    Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is available.

    Distribution

    Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada

    Quantity

    59 units