Events

Recall of Device Recall Trilogy Mx Radiotherapy Delivery System

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
    58994
  • Event Risk Class
    Class 2
  • Event Number
    Z-2766-2011
  • Event Initiated Date
    2011-05-19
  • Event Date Posted
    2011-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100785
  • 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
    Imaging arms of the truebeam accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.
  • Action
    Varian Medical Systems, Inc. Oncology Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 19, 2011, via certified mail, return receipt requested in the US. The letter identified the product, problem and recommended actions to be taken. For additional information contact Varian Customer Support at 1-888- 827-4265.

Device

Device Recall Trilogy Mx Radiotherapy Delivery System
  • Model / Serial
    Model numbers: H14, H19, H27, H29. Serial numbers: H191001 H191012 H191022 H191032 H191043 H191054 H191066 H191083 H191002 H191013 H191023 H191033 H191044 H191055 H191067 H191085 H191003 H191014 H191024 H191034 H191045 H191056 H191070 H191086 H191005 H191015 H191025 H191035 H191046 H191057 H191071 H191089 H191006 H191016 H191026 H191036 H191047 H191058 H191072 H191090 H191007 H191017 H191027 H191037 H191048 H191059 H191076 H191091 H191008 H191018 H191028 H191038 H191049 H191060 H191077 H191092 H191009 H191019 H191029 H191039 H191051 H191061 H191078  H191010 H191020 H191030 H191041 H191052 H191063 H191079  H191011 H191021 H191031 H191042 H191053 H191064 H191080
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and countries of: Canada, Denmark, France, Germany, Isreal, Italy, Netherlands, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    TrueBeam Linear Accelerators (aka Trilogy Mx) || Varian Medical Systems, Palo Alto, CA || Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated.
  • 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