Events

Recall of Device Recall VariSource iX series

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
    71451
  • Event Risk Class
    Class 2
  • Event Number
    Z-1849-2015
  • Event Initiated Date
    2015-05-18
  • Event Date Posted
    2015-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137840
  • 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
    After an application freeze and restart of the varisource ix series by power cycling, the partial fraction generated by the system will not be correct. the application freeze issue affects only the systems equipped with magnetic hard disk drives (hdd).
  • 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 VariSource iX series
  • Model / Serial
    JAQ
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
  • 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