Events

Recall of Device Recall Treatment Planning and Delivery System Software version 3.6. ViewRay

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
    71505
  • Event Risk Class
    Class 2
  • Event Number
    Z-1954-2015
  • Event Initiated Date
    2015-05-07
  • Event Date Posted
    2015-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138008
  • 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 failing to determine new patient locations if imaging is not enabled during treatment.
  • Action
    On May 7, 2015 the firm sent Customer Advisory Notification Letters to their customers.

Device

Device Recall Treatment Planning and Delivery System Software version 3.6. ViewRay
  • Model / Serial
    Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, MO & WI.
  • Product Description
    Treatment Planning and Delivery System Software version 3.6. ViewRay. || Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
  • 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