Events

Recall of Device Recall 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. Oncology Systems.

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
    59401
  • Event Risk Class
    Class 2
  • Event Number
    Z-2993-2011
  • Event Initiated Date
    2011-07-13
  • Event Date Posted
    2011-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102637
  • 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
    Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.
  • Action
    Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated July 13, 2011 to all possibly affected customers. This notification supplements and modifies the previous "Customer Technical Bulletins" originally sent in September 2008. The initial Customer Technical Bulletins informed customers of the possibility that needle tips cans crack and separate. It also reminded users that the product has a limited life and to check needles prior to use as per instructions. Current correction notice letter instruct customers to stop using any plastic needles in inventory with lot numbers C01 to D01 and those with lot numbers starting with H or I. The letter also request that the recalled products be returned to Varian BrachyTherapy for replacement. The letters include information as to where the lot number is located on the device. All appropriate personnel should be notified of the correction notice. Contact information is provided for all geographical areas. USA contact for questions or concerns is 1-800-360-7909.

Device

Device Recall GammaMed Plastic Needle with Mandrin
  • Model / Serial
    Part numbers GM11007580;  All lots C01 to D01 and lots H and I
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, Nepal New Zealand, Norway, Pakistan, Philippines, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Arab Emirates Uruguay, United Kingdom, and Venezuela.
  • Product Description
    GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 320 mm. || Remote controlled radionuclide applicator system. || Varian Medical Systems, Inc. || Mfg by Varian Medical Systems Haan GmbH, Haan, Germany || Product Usage: 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. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA