BEUDAMED
    FDA Recall Terminated

    GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.

    Recall: Z-0328-2012 · Initiated September 30, 2008

    Recall

    Recall Number
    Z-0328-2012
    Event Number
    59779
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    3000206172
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 30, 2008
    Posted
    December 1, 2011
    Terminated
    December 7, 2011
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    Description

    GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.

    Reason

    Plastic needle tip could possibly crack or separate.

    Action

    Varian Medical Systems sent a "CUSTOMER TECHNICAL BULLETIN" letter dated September 30, 2008 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed users to inspect needle tips before and after every clinical application to prevent needle tip separation or cracking.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of Arizonia, California, Florida, Illinois, Indiana, Michigan, North Carolina, and Vermont, and the countries of Argentina, Austria, Belgium, Canada, Estonia, France, Germany, India, Norway, Pakistan, Russia, Slovenia, So. Africia, Spain, Switzerland, United Kingdom, and Ukraine.

    Quantity

    1716 parts