BEUDAMED
    FDA Enforcement Class II Terminated

    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    Recall: Z-1829-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1829-2015
    Event ID
    71450
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 1, 2015
    Initiation Date
    May 18, 2015
    Classification Date
    June 23, 2015
    Termination Date
    January 26, 2016
    Address
    501 Locust Ave, Charlottesville, VA, 22902-4869, United States

    Description

    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    Reason

    Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat

    Code Info

    JAQ

    Distribution

    Worldwide Distribution.

    Quantity

    46