Events

Recall of Device Recall 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
    60837
  • Event Risk Class
    Class 2
  • Event Number
    Z-0736-2012
  • Event Initiated Date
    2011-12-12
  • Event Date Posted
    2012-01-13
  • 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=106612
  • 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
    An anomaly has been identified with the eclipse treatment planning system when planning for the siemens multileaf collimator (mlc) where a virtual jaw can be positioned inside the mlc aperture and then used as the beam limiting device for the dose calculation. this will result in an incorrect dose distribution within eclipse.
  • Action
    Varian Medical Systems sent a Urgent Medical Device Correction letter dated December 12, 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 identified the product the problem and the action needed to be taken by the customer. Customers were instructed to pay careful attention to any warnings displayed regarding the Virtual Collimator Jaws when the plan is calculated. If the warning indicates that the Virtual Collimator Jaws are inside the MLC aperture, do not proceed with the calculation. Varian is continuing to evaluate possible technical solutions for this issue. Special Instructions for customers outside the USA and Canada: In order to satisfy regulatory requirements, we request that you complete the attached Proof of Notification or Receipt Verification Card once you have read this document and return it to Varian Medical Systems. "We sincerely apologize for any inconvenience and thank you in advance for your cooperation." Please call for USA and Canada: 1.888.VARIAN5 (888.827.4265) Europe: +41 41 749 8844.

Device

Device Recall Varian brand Eclipse Treatment Planning System
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution -- USA (nationwide) including the countries of Canada and Europe.
  • Product Description
    Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; || Reference/FSCA Identifier: CP-07007, 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 eye.
  • 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