BEUDAMED
    FDA Recall Terminated

    Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.

    Recall: Z-1324-2013 · Initiated April 11, 0013

    Recall

    Recall Number
    Z-1324-2013
    Event Number
    64986
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    3000206172
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 11, 0013
    Posted
    May 15, 2013
    Terminated
    January 13, 2014
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    Description

    Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.

    Reason

    Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.

    Action

    Varian Medical Systems, Inc. notified customers of the recall with 'Urgent Medical Device Correction Urgent Field Safety Notice," dated 4/11/13, and delivered by mail to customers. The notice identified the product, problem, and instructions for the customers. Varian Medical Systems, Inc. informed customers of the possible malfunction of the GM11004150 Segmented Cylinder Applicator Set for pulsed dose rate brachytherapy treatment, with codes H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387. The notice instructed customers to cease use of the Segmented Cylinder Applicator Set and return the devices along with a completed proof of notification form (included with the recall notice) to the recalling firm.

    Distribution

    Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.

    Quantity

    21 devices