Events

Recall of Device Recall Regulation Number 892.5700

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
    61179
  • Event Risk Class
    Class 2
  • Event Number
    Z-1199-2012
  • Event Initiated Date
    2012-01-05
  • Event Date Posted
    2012-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107467
  • 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
    Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
  • Action
    Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice letter dated January 5, 2012 to all affected consignees. The letter identified the affected products, description of problem and recommended user actions to be taken. Consignees were requested to cease use of the affected products and contact Varian BrachyTherapy Helpdesk immediately to arrange return of their affected parts. Consignees were requested to return the enclosed proof of notification form. Consignees were instructed to advise the appropriate personnel working in their radiotherapy department of the content of this letter. For future reference, this document will be posted to the Varian Customer Support website: http://www.MyVarian.com. For further clarification contact your local Varian District or Regional Manager.

Device

Device Recall Regulation Number 892.5700
  • Model / Serial
    All lots of the components are recalled. Components are used as adapters for the Varian Afterloaders with the following serial numbers:  H600097 H600254 H600255 H600268 H600274 H600341 H600345 H600352 H600377 H600381 H600416 H600435 H600437 H600462 H600513 H600524 H600538 H600546 H600548 H600583
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Including the states of CA, FL, IN, KY, MI, MN, MO, OH, TX, VA and the countries of Canada, Japan and Sweden.
  • Product Description
    Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. || Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.
  • 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