Events

Recall of Varian Eclipse

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

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
    56772
  • Event Risk Class
    Class 2
  • Event Number
    Z-0911-2011
  • Event Initiated Date
    2010-08-17
  • Event Date Posted
    2011-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94479
  • 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 therapy planning system - Product Code MUJ
  • Reason
    Possible incorrect dose calculation: an anomaly in certain eclipse versions where, under certain specific sequences of user actions, the dose distribution may fail to be re-calculated even though changes have been made which affect dose.
  • Action
    Varian Medical Systems Urgent Medical Device Correction letters were sent to all affected users on August 6, 2010. Letters were also sent to Varian Sales, Marketing and Service organizations to inform them of the recall.

Device

Varian Eclipse
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System
  • Manufacturer
    Varian Medical Systems, Palo Alto, CA

Manufacturer

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