Events

Recall of Device Recall Variseed 7.1

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
    61364
  • Event Risk Class
    Class 2
  • Event Number
    Z-1385-2012
  • Event Initiated Date
    2012-01-25
  • Event Date Posted
    2012-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107920
  • 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
    Source, brachytherapy, radionuclide - Product Code KXK
  • Reason
    Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment.
  • Action
    Varian Medical Systems notified direct account healthcare practitioners/ medical physicists with "Urgent Medical Device Correction/Urgent Field Safety Notice" letters by mail on 01/19/2012. Varian's advisory described how to mitigate user error and the firm's intentions to revise Instructions for Use. Technical Support phone numbers were provided for US and international customers.

Device

Device Recall Variseed 7.1
  • Model / Serial
    device is not coded
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution
  • Product Description
    VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.
  • 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