Events

Recall of Varian Head Frame

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
    75296
  • Event Risk Class
    Class 2
  • Event Number
    Z-0077-2017
  • Event Initiated Date
    2016-09-13
  • Event Date Posted
    2016-10-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149994
  • 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 medical systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. there was no report of serious injury due to this issue.
  • Action
    Varian Medical Systems sent an Urgent Medical Device Removal letter dated September 14, 2016, to all affected sites. Each site was also contacted by telephone to advice users of the issue and request of return of the head frame posts on September 14 and 15th. Calls enabled Varian to prioritize replacement parts for those with patients scheduled in the immediate future. Recommended User Actions: 1.CEASE USE of the Varian Head Frame Assembly and QUARANTINE the Varian Head Frame Assembly and components. 2.Collect, Clean, Disinfect all Head Frame Posts [PN1008016] if used previously. 3.Contact Varian 1.888.827.4265 for Return Material Authorization number, and return all Head Frame Posts in accordance with instructions provided with the enclosed Recall Return Material Form. 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.

Device

Varian Head Frame
  • Model / Serial
    All Head Frame Posts and Post kits
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution and Internationally to 1 site in Canada, India and Morocco
  • Product Description
    Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). || The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
  • 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