Events

Recall of Device Recall Surface Applicator Set with Leipzigstyle Cone

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
    71450
  • Event Risk Class
    Class 2
  • Event Number
    Z-1829-2015
  • Event Initiated Date
    2015-05-18
  • Event Date Posted
    2015-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137839
  • 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
    Varian has discovered that there is a discrepancy in the absolute dose rate given with the leipzig-style surface applicator's instructions for use (ifu): dose characterization gm11010080 2012-09-06. the actual dose rate of the applicator is approximately 14% higher than the rate published within the ifu. use of the dose rate as provided by the ifu without modification or independent confirmat.
  • Action
    All the consignees affected by this recall will be notified by: The Urgent Medical Device Correction Letter/ Field Safety Notification will be distributed to all affected users, with a description of the problem. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. Additionally, the letter will be posted to the customer support site: http:/ /www.MyVarian.com.

Device

Device Recall Surface Applicator Set with Leipzigstyle Cone
  • Model / Serial
    JAQ
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Surface Applicator Set with Leipzig-style Cone. || Brachytherapy applicator set.
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Manufacturer Address
    Varian Medical Systems Inc, 501 Locust Ave, Charlottesville VA 22902-4869
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA