Events

Recall of Varian Medical System TrueBeam

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
    58590
  • Event Risk Class
    Class 2
  • Event Number
    Z-2181-2011
  • Event Initiated Date
    2011-04-05
  • Event Date Posted
    2011-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99646
  • 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
    stereotactic radiosurgery and radiotherapy system - Product Code IYE
  • Reason
    Position sensor failure mode may result in an inaccurate position calculation. 1. the video returned by one of the two cameras inside the spectra is all white or all black, and the spectra stops tracking. or 2. certain video intensities are not available on one of the two cameras. the image has abnormally abrupt transitions from dark to light portions, without the normal shades of gray.
  • Action
    Varian Urgent Medical Device Correction, Urgent Field Safety Notice letters were sent to all affected facilities by certified mail on April 5, 2011.

Device

Varian Medical System TrueBeam
  • Model / Serial
    Model number H19; Code numbers: H191011, H191019, H191027, H191033, H191012, H191021, H191028, H191037, H191013, H191023, H191030, H191043, H191016, H191025, H191031, H191045, H191018, H191026, H191032, H191047.  Affected NDA Serial numbers: P7-03112, P7-03174, P7-03221.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
  • 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