Events

Recall of Device Recall MRIdian ViewRay Radiation Therapy System, 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
    72166
  • Event Risk Class
    Class 2
  • Event Number
    Z-0115-2016
  • Event Initiated Date
    2015-08-27
  • Event Date Posted
    2015-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140076
  • 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
    System, radiation therapy, radionuclide - Product Code IYE
  • Reason
    Viewray discovered that in the event that an encoder breaks or fails on the patient handling system (phs, or couch), when attempting to restart the system, the couch could move unexpectedly.
  • Action
    ViewRay sent an Customer Advisory Notice dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It is recommended that if you have a patient on the couch and you receive the fault ''The patient table has experienced an unintended movement. This may be due to the patient or operator leaning on the table. Clear the fault and retry. If the problem persists call Service" on the TPDS,first attempt to clear the fault. If it does not clear and requires you to restart the couch software (same switch as restarting the RTCS) you should manually remove the patient from the couch before restarting the system. A software patch to address this issue is planned for early 2016. In the meantime please practice our recommendation of removing the patient from the couch prior to restarting the RTCS. 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 MRIdian ViewRay Radiation Therapy System, ViewRay
  • Model / Serial
    Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
  • Product Description
    MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ || Is 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