Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MRIdian ViewRay Radiation Therapy System, ViewRay

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall MRIdian ViewRay Radiation Therapy System, ViewRaysee related information
Date Initiated by FirmAugust 27, 2015
Date PostedOctober 09, 2015
Recall Status1 Terminated 3 on June 09, 2017
Recall NumberZ-0115-2016
Recall Event ID 72166
510(K)NumberK111862 
Product Classification System, radiation therapy, radionuclide - Product Code IYE
ProductMRIdian 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.
Code Information Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
FEI Number 3007546534
Recalling Firm/
Manufacturer		 Viewray Incorporated
2 Thermo Fisher Way
Oakwood Village OH 44146-6536
For Additional Information ContactMr. Garth M. Nobis
650-252-0925
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionViewRay 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.
Quantity in Commerce4 units
DistributionUS Distribution to the states of : CA, MO and WI., and Internationally to Korea.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = IYE
-
-