Events

Recall of GammaMed Plastic Needle with Mandrin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59779
  • Event Risk Class
    Class 2
  • Event Number
    Z-0326-2012
  • Event Date Posted
    2011-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103723
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, applicator, radionuclide, remote-controlled - Product Code JAQ
  • 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.

Device

GammaMed Plastic Needle with Mandrin
  • Model / Serial
    Part number GM11007560
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 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.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.
  • Manufacturer Address
    Varian Medical Systems, Inc., 700 Harris St Ste 109, Charlottesville VA 22903-4584
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA