Events

Recall of Varian

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
    36556
  • Event Risk Class
    Class 2
  • Event Number
    Z-0304-2007
  • Event Initiated Date
    2006-09-21
  • Event Date Posted
    2006-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48896
  • 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
    radiation therapy system - Product Code IYE
  • Reason
    Selecting an empty space next to the ''override'' or ''acquire actual'' buttons may result in mistreatment to the patient.
  • Action
    On September 21, 2006, the firm issued letters via certified mailing with return receipt to all its direct consignees, informing them of the affected product and providing instructions on the recall.

Device

Varian
  • Model / Serial
    All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, with Serial numbers H510946, H510651, H510190
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Defense Supply Center, VA or other Federal Government sales/distribution centers include: V.A. Medical Center, Atlanta, Dept. of Radiation Oncology, 1670 Clairmont Rd., Decatur, GA, 30030; V.A. Medical Center of Long Beach, Dept. of Rad. Oncology, 5901 E. 7th St., Long beach, CA 90745; V.A. Medical Center, Department of Rad. Oncology, 4646 John R Street, Detroit, MI 48201; V.A. Medical Center-Jackson, Radiology Oncology, 1500 E. Woodrow-Wilson Ave., Jackson, MS 39216; V.A. West Los Angeles Medical Center, Dept., of Radiology Therapy, 11301 Wilshire Blvd., Building 345, Rm. 124, Los Angeles, CA 90073; V.A. Medical Center, 50 Irving Street NW, Washington, DC 20422; Blount Memorial Hospital, Radiology Oncology, 907 E. Lamar Alexander Pkwy., Maryville, TN 37804. Canadian distribution include: British Valley Cancer, 600 W. 10th Avenue, Vancouver, BC, V5Z 4E6, Canada; Fraser Valley Cancer, Radiology Oncology, 13750 96th Ave., Surrey, BC, V3V 1Z2, Canada; BHUM-Notre Dame Campus, Radiation Oncology Physics, 1560, Rue, Sherbrooke Est. Montreal, PQ, H2L 4M1, Canada. Other foreign distribution include: Australia, Austria, Bahrain, Belgium, Belorussia, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia & Montenegro, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam.
  • Product Description
    4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; || All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, with Serial numbers H510946, H510651, H510190.
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Manufacturer Address
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304-1038
  • Source
    USFDA