Events

Recall of Device Recall ViewRay Radiation Therapy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Viewray Incorporated.

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
    71050
  • Event Risk Class
    Class 2
  • Event Number
    Z-1580-2015
  • Event Initiated Date
    2015-01-15
  • Event Date Posted
    2015-05-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135930
  • 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
    The software was not correctly using the rt (radiation therapy) to mr (magnetic resonance image) coordinate correction for non hfs (head first supine) patient orientations, resulting in slice mismatch error.
  • Action
    On January 15, 2014, ViewRay personnel discussed the investigation of the issue (slice mismatch error) with the customer. The firm advised the customer that until the issue was corrected, to not treat patients in non HFS orientations, or to use the MR acquired from the ViewRay system as the primary plan series for non HFS scans. ViewRay installed software version 3.4.5.28 on January 20 and 21, 2014, in order to prevent this slice mismatch error from occurring in any patient position.

Device

Device Recall ViewRay Radiation Therapy System
  • Model / Serial
    M/N 10000, S/N 100 only
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to MO.
  • Product Description
    ViewRay System, Radiation Therapy System
  • Manufacturer
    Viewray Incorporated

Manufacturer

Viewray Incorporated
  • Manufacturer Address
    Viewray Incorporated, 2 Thermo Fisher Way, Oakwood Village OH 44146-6536
  • Manufacturer Parent Company (2017)
    ViewRay, Inc.
  • Source
    USFDA