Events

Recall of Varian OnBoard Imager

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
    38349
  • Event Risk Class
    Class 2
  • Event Number
    Z-1195-2007
  • Event Initiated Date
    2007-04-18
  • Event Date Posted
    2007-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53471
  • 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
    Medical Linear Accelerator - Product Code IYE
  • Reason
    Patient positioning errors may occur because of mechanical variations during product installation.
  • Action
    The firm issued a notification letter to all customers April 18, 2007. The firm intends to arrange for service personnel to contact affected sites to verify the calibration of the OBI system, and make arrangements to correct any issues. The firm will also update installation manuals to clearly describe the OBI installation and calibration requirements.

Device

Varian OnBoard Imager
  • Model / Serial
    serial numbers H070002-H072113
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Puerto Rico, Australia, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Italy, Japan, Luxembourg, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Netherlands, and United Kingdom.
  • Product Description
    Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Manufacturer Address
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304
  • Source
    USFDA