BEUDAMED
    FDA Recall 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 · Initiated August 9, 2013

    Recall

    Recall Number
    Z-0065-2014
    Event Number
    66121
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    3000206172
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 9, 2013
    Posted
    October 24, 2013
    Terminated
    April 10, 2014
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    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.

    Action

    Urgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013.

    Distribution

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

    Quantity

    3 sets