Events

Recall of Device Recall Eclipse Release 6.5 through 10 (build 7.3.10 through 10.0.34)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc. 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
    58969
  • Event Risk Class
    Class 2
  • Event Number
    Z-2780-2011
  • Event Initiated Date
    2011-05-13
  • Event Date Posted
    2011-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100741
  • 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
    Radiation Treatment Planning System - Product Code MUJ
  • Reason
    In affected eclipse versions, user editing of the mlc leaf positions may not automatically invalidate calculated dose distributions.
  • Action
    Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter included the description of the product, problem and recommendations and includes the release of a service pack in the future. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)

Device

Device Recall Eclipse Release 6.5 through 10 (build 7.3.10 through 10.0.34)
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: Nationwide (USA) and the country of Canada.
  • Product Description
    Eclipse Treatment Planning System; Release 6.5 through 10 || (build 7.3.10 through 10.0.34) || Varian Medical Systems, Inc. || Used to plan radiotherapy treatments for patients with Malignant or benign diseases. Plans beam irradiation with photon, electron and proton beams, as well as for internal radiation treatments.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

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