Events

Recall of Patient Handling 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
    71555
  • Event Risk Class
    Class 2
  • Event Number
    Z-2085-2015
  • Event Initiated Date
    2015-04-01
  • Event Date Posted
    2015-07-16
  • 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=138433
  • 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
    Viewray received a report that the couch moved unexpectedly into the bore after performing a rtcs reboot.
  • Action
    ViewRay sent a Customer Advisory Notification Letters dated April 1, 2015 to thier customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns regarding this issue, contact ViewRaylM Customer Support at support@viewray.com or call the ViewRaylM Customer Support center at 855-286-8875.

Device

Patient Handling System
  • Model / Serial
    Model #10000, Serial #'s: 100, 101, and 102
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CA, MO & WI
  • Product Description
    Patient Handling System (Motion Control Software), || Product Usage: || 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