Events

Recall of Device Recall GammaMed Flexible Applicator

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
    59388
  • Event Risk Class
    Class 2
  • Event Number
    Z-3013-2011
  • Event Initiated Date
    2011-07-13
  • Event Date Posted
    2011-08-12
  • 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=102571
  • 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
    Radionuclide System Applicator, Remote-Controlled - Product Code JAQ
  • Reason
    Certain gammamed flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
  • Action
    Varian Medical Systems, Inc. sent out Customer Technical bulletins in August 2008 and Urgent Medical Device Correction/Urgent Field Safety Notices on July 13, 2011 to all affected customers. The letter included description of device and problem. The current notice supplements and modifies previous instructions and ask that they stop using any flexible applicator probes in inventory. They are to be returned to Varian Brachy Therapy for replacement. Letter go on to list possible scenarios if the length deviation is not detected and advised all personnel working in the radiotherapy department should be notified of the recall. For additional information contact (800) 360-7909.

Device

Device Recall GammaMed Flexible Applicator
  • Model / Serial
    Lots D01 to H14; Part number GM1102560
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide (USA) and including the countries of France, Germany, India, Trinidad and Tobago, United Kingdom, Canada, Nepal, Ukraine, Czech Republic, Bangladesh, Thailand, Turkey, Brazil, Estonia, Switzerland, Russia, Greece, Philippines, Spain, Belgium, Kuwait, Romania, Morocco, Mexico, Columbia, Austria, Poland, Kazahstan, Vietnam, Cyprus, New Zealand, Dominican Republic, Norway, Uzebestan, Hungary, Lebanon, South Africa, South Korea, Slovenia, Venezuela, Serbia, Tunisia, Pakistan, Macedonia, Ireland, Azerbajian, Ukraine, Morroco, Italy, Singapore, Nambia, Turkey, Sudan, and Taiwan.
  • Product Description
    GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF. || Varian Medical Systems, Palo Alto, CA. || Mfg by Varian Medical Systems, Haan GmbH. || Flexible Applicator Robes are designed for brachytherapy intracavitary treatments in areas such as vagina, vagina stump or rectum.
  • 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