Events

Recall of Device Recall Eclipse Treatment Planning System version 13.MR2

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
    76018
  • Event Risk Class
    Class 2
  • Event Number
    Z-0990-2017
  • Event Initiated Date
    2016-12-02
  • Event Date Posted
    2017-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151945
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Modifications in version 13.6mr2 for contouring, smartadapt, and smartsegmentation workspaces resulted in contours not being saved consistently in eclipse. treatment planning system. the issue only occurs if certain conditions are fulfilled.
  • Action
    Varian Medical Systems sent an Urgent Medical Device Correction Letter dated December 5, 2016 , that were sent to all 5 affected sites on December 5, 2016 by a trackable method. Letters advised users of the issue and the specific scenario that must take place for the issue to occur. Varian is investigating the issue and will provide a correction once it is available. We sincerely apologize for any inconvenience and thank you in advance for your cooperation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager. This notice has been provided to the appropriate Regulatory Authorities. For further questions please call (650) 424-6833. Varian Oncology Help Desk Contact Information: Phone: +1.888.827.4265 Email: support @varian.com

Device

Device Recall Eclipse Treatment Planning System version 13.MR2
  • Model / Serial
    Model # H48  Serial numbers: H48L574 H48L575 H48L576 H48L577 H48L578 H48L579 H48L580 H48L581 H48L582 H48L583 H48L584 H48L585 H48L586 H48L587 H482484 H487302 H48A587 H48D957 H480113 H480118 H481884 H481885 H481886 H481916 H481917 H484198 H484199 H488949 H48A680 H48A871 H48A872 H48A873 H48A874 H48A875 H48A876 H48A877 H48A878 H48A879 H48I531 H481195 H481236 H481237.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : NJ, TN. OR and FL.
  • Product Description
    Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] || Radiology: 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.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

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