Events

Recall of VARISOURCE Breast Template System for high-dose rate Brachytherapy.

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
    66121
  • Event Risk Class
    Class 2
  • Event Number
    Z-0065-2014
  • Event Initiated Date
    2013-08-09
  • Event Date Posted
    2013-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121521
  • 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
    The recall was initiated after varian medical became aware the lexan templates of the breast bridge template system could become bent and turn opaque after steam sterilization.
  • Action
    Urgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013.

Device

VARISOURCE Breast Template System for high-dose rate Brachytherapy.
  • Model / Serial
    Lots #6078184-1, #6078184-2, #6078184-4
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
  • Product Description
    VARISOURCE Breast Template System for high-dose rate Brachytherapy. || ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
  • 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