BEUDAMED
    FDA Enforcement Class II Terminated

    VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA

    Recall: Z-0065-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0065-2014
    Event ID
    66121
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2013
    Initiation Date
    August 9, 2013
    Classification Date
    October 24, 2013
    Termination Date
    April 10, 2014
    Address
    700 Harris St Ste 109, N/A, Charlottesville, VA, 22903-4584, United States

    Description

    VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA

    Reason

    The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.

    Code Info

    Lots #6078184-1, #6078184-2, #6078184-4

    Distribution

    Worldwide distribution: US (nationwide) distribution in CA and in the country of India.

    Quantity

    3 sets