Events

Recall of Device Recall ViewRay MRIdian

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
    73086
  • Event Risk Class
    Class 2
  • Event Number
    Z-0806-2016
  • Event Initiated Date
    2015-12-24
  • Event Date Posted
    2016-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143035
  • 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 system loaded a completion fraction in the incorrect order after a treatment interruption.
  • Action
    ViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan. While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected with the completion plan. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at support@viewray.com or call the ViewRay" Customer Support center at 855-286- 8875.

Device

Device Recall ViewRay MRIdian
  • Model / Serial
    Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
  • Product Description
    MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
  • 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