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 ViewRay Maridian System

  • 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 ViewRay Maridian System see related information
Date Initiated by Firm March 07, 2016
Date Posted March 31, 2016
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-1309-2016
Recall Event ID 73550
510(K)Number K111862  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated
Code Information Model number: 10000 Catalog/Part Number: 10000 Serial Numbers: 100, 101, 102, 104 & 105 
Recalling Firm/
Manufacturer		 Viewray Incorporated
2 Thermo Fisher Way
Oakwood Village OH 44146-6536
For Additional Information Contact Mr. Garth M. Nobis
800-252-0925
Manufacturer Reason
for Recall		 When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
FDA Determined
Cause 2		 Software design
Action ViewRay sent an Urgent Device Correction letter dated March 7, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact ViewRay Customer Support at support@viewray.com or call the ViewRay Customer Support center at 855-286-8875.
Quantity in Commerce 5 units
Distribution Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IYE and Original Applicant = VIEWRAY INCORPORATED
-
-