Events

Recall of Varian brand Eclipse Treatment Planning System

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
    63093
  • Event Risk Class
    Class 2
  • Event Number
    Z-2462-2012
  • Event Initiated Date
    2012-08-17
  • Event Date Posted
    2012-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112531
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    Varian has identified an anomaly with the eclipse treatment planning where an outdated assigned hounsfield unit [hu] value can be used for dose calculation when the clock on the eclipse client workstation is not synchronized with the database/system server. treatment of the patient using these values can therefore lead to under or over-dose.
  • Action
    VARIAN Medical Systems sent an Urgent Medical Device Correction Urgent Field Safety Notice on August 17, 2012, to all affected customers with a description of the problem and user corrective action steps. Customers were instructed to ensure that the workstation clock be synchronized with the DatabaseSystem server clock. Customers were also instructed to contact Varian service for assistance with time synchronization if required. Customers were to complete the attached Proof of Notification Form once they have read the document and return it to Varian Medical Systems. For questions customers should call the following numbers: USA and Canada 1-888-827-4265. Europe +41 41 749 8844. For questions regarding this recall call 650-424-5731.

Device

Varian brand Eclipse Treatment Planning System
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally. . .
  • Product Description
    Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 || Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
  • 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