Events

Recall of Device Recall Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear

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
    58970
  • Event Risk Class
    Class 2
  • Event Number
    Z-2778-2011
  • Event Initiated Date
    2011-05-13
  • Event Date Posted
    2011-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100743
  • 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
    Linear Accelerator for Radiation Therapy System - Product Code IYE
  • Reason
    Some drive stand bolts may fail to meet mechanical specifications.
  • Action
    Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers. The letter included a description of product, problem and recommendations. This includes performing daily QA to detect isocenter shift and the use of independent patient position system. Customers are advised to discontinue its use if a shift is detected and to contact Varian Medical Systems for a replacement stand bolts and adjustment if necessary. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)

Device

Device Recall Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear
  • Model / Serial
    H14, H19, H27, H29. Serial Numbers:  H140927 H191045 H294986 H295004 H295021 H295036 H140929 H191048 H294988 H295010 H295025 H295042 H140932 H191049 H294989 H295012 H295031 H295047 H140934 H191050 H294999 H295013 H295032 H295051 H191035 H272973 H295001 H295014 H295033 H295058 H191044 H294979 H295002 H295015 H295034 H295068
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: (USA) Nationwide including the states of PA. NJ, NY, MA, VA, TX, KS, FL, OH, SC, MN, CA, TN and NV; and the countries of Canada, Colombia, France, Italy, Japan, Netherlands and United Kingdom.
  • Product Description
    Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands || Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • 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