Events

Recall of Device Recall Varian RV Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems Oncology Systems.

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
    48661
  • Event Risk Class
    Class 2
  • Event Number
    Z-0164-2009
  • Event Initiated Date
    2008-06-02
  • Event Date Posted
    2008-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71829
  • 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
    Medical Linear Accelerator - Product Code IYE
  • Reason
    A malfunction within the varis software might result in a misadministration (underdose). the software does not correctly interpret the number, causing field parameters having decimal values to be incorrect.
  • Action
    Recall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees.

Device

Device Recall Varian RV Software
  • Model / Serial
    H462082, H463052, H462031, H463016, H462001, H462075, H462079, H462005, H462006, H462016, H462017, H462021, H462022, H462023, H462024, H463024, H463377, H463017.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK.
  • Product Description
    Varian RV Software || Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; || Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing irradiation while any parameter is out of conformance with the treatment plan.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

Varian Medical Systems Oncology Systems
  • Manufacturer Address
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA