Events

Recall of Elekta VBH Head FIX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, 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
    57111
  • Event Risk Class
    Class 2
  • Event Number
    Z-0538-2011
  • Event Initiated Date
    2010-10-14
  • Event Date Posted
    2010-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95410
  • 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
    The headfix baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the headfix leveling screws of the headfix baseplate.
  • Action
    Elekta, Inc. sent an Important Notice A343 dated October 14, 2010 to all affected consignees. The Notice identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed constantly monitor the patient before and during the treatment. Check the patient's position after every patient movement (e.g. coughing). Advise all appropriate personnel of the content of the notice place a copy of the Notice In the Important Notice Section of the HeadFix User Manual P10103-108. For questions regarding this recall service.schwabmuenchen@elekta.com

Device

Elekta VBH Head FIX
  • Model / Serial
    P10103
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, CA, CT, FL, GA, IL, KY, MI, MS, NY, NC, OK, OR, RI, TN, TX, VA, WA and the country of Canada
  • Product Description
    Elekta VBH Head FIX || The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA