Events

Recall of Device Recall VARIAN HIGH ENERGY LINEAR ACCELERATOR

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
    58438
  • Event Risk Class
    Class 2
  • Event Number
    Z-2195-2011
  • Event Initiated Date
    2011-03-28
  • Event Date Posted
    2011-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99348
  • 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
    Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail.
  • Action
    The firm, Varian Medical, sent an "Urgent Medical Device Correction" Letter dated March 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect all hard wedges for missing or sheared screw fasteners, if any wedge is found to have one or more missing or sheared screw fasteners, remove the wedge from use and notify Varian immediately; inspect all hard wedges for loose screw fasteners, and retighten as necessary, and implement a program of monthly inspection of wedges for loose or missing hardware. The customers were also instructed to advise the appropriate personnel working in their Radiotherapy Department of the content of this letter. Varian Service shall immediately begin an interim action to replace screw fasteners on all hard wedges for Clinacs installed prior to January 2004. Varian Service will contact the customers to arrange for the inspection visit. Varian also stated that they shall continue their Investigation of this issue to further clarify the exact conditions under which the wedge screw fasteners may fail, and to analyze possible final solutions. Varian will notify the customers when final determinations are made. If you require further clarification, please feel free to contact your local Varian Customer Support Services Manager and/or USA and Canada at 1-888-4265; Europe: +41 41 749 8844; or email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.Helpdesk@varian.com; Japan: Japan.apps helpdesk@varian.com; Latin America: soporte.al@varian.com, a d Internet: Oncology Systems-www.myvarian.com or Varian Medical Systems - www.varian.com.

Device

Device Recall VARIAN HIGH ENERGY LINEAR ACCELERATOR
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution:
  • Product Description
    Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases.
  • 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