BEUDAMED
    FDA Recall Terminated

    Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150)

    Recall: Z-0282-2012 · Initiated May 20, 2010

    Recall

    Recall Number
    Z-0282-2012
    Event Number
    59913
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    3000206172
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    May 20, 2010
    Posted
    November 23, 2011
    Terminated
    December 5, 2011
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    Description

    Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150)

    Reason

    The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer.

    Action

    Varian Medical Systems sent a Medical Device Recall (PNL-GM-42697-2) in May 2010 for the blocking washer on the flexible probe, Varian part number GM11002420, a component of the Segmented Cylinder Applicator Set. The letter was to inform users that a flexible probe with an unstable or shifted blocking washer must not be used due to the potential for treatment length error. The blocking washer may move from rough handling or sterilization. Users were told to discard any instances of the obsolete Instructions for Use (IFU) in use and replace it with the IFU (PGM11004150 4 March 24, 2010.pdf). A Receipt Verification Card was included requesting consignees to fill out, fax or e-mail immediately to Varian BrachyTherapy.

    Distribution

    Worldwide Distribution: USA, Germany, Belgium, Canada, Mexico City, Spain, Brazil, Switzerland, Uzbekistan, India

    Quantity

    81 parts