Events

Recall of Device Recall 4D Intergrated Treatment Console

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
    58230
  • Event Risk Class
    Class 2
  • Event Number
    Z-2119-2011
  • Event Initiated Date
    2011-02-28
  • Event Date Posted
    2011-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98761
  • 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
    A software anomaly, in that the multileaf collimator (mlc) message displayed on the 4ditc on versions 8.6 and below, does not interlock beam delivery.
  • Action
    Varian Medical Systems sent an Urgent Medical Device Correction Letter on February 28, 2011, to all affected customers. Varian has created the procedure described in CTB-GE-579 to inform users on proper interfacing of the demountable BrainLAB m3 on the Varian Clinac. The procedure ( CTB-GE-579) is enclosed and posted to the customer site: http://www.MyVarian.com. This design fix in 4DITC v10.1 or later will be provided to all affected sites. If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager. USA and Canada - 1-888-VARIANS (888-827-4265) Europe - + 41 41 749 8844

Device

Device Recall 4D Intergrated Treatment Console
  • Model / Serial
    Affected Serial Numbers:  H510378, H510392, H510712, H510844, H511781, H512506, H512547, H512645, H513143, H513196, H513460, H514034, H514385, H514468, H514759, H514941, H511891
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class 2 Recall - Worldwide Distribution -- USA including states of ; CA, NV, NJ, GA, IL, and TX and countries of Australasia, Belgium, Brazil, China P.R., Denmark, France, Germany, Germany ( BrachyTherapy) Hong Kong, India Pvt. Ltd, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland and United Kingdom.
  • Product Description
    The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
  • 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