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 Patient Handling 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 Patient Handling System see related information
Date Initiated by Firm April 01, 2015
Date Posted July 16, 2015
Recall Status1 Terminated 3 on February 04, 2016
Recall Number Z-2085-2015
Recall Event ID 71555
510(K)Number K111862  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 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.
Code Information Model #10000, Serial #'s: 100, 101, and 102
Recalling Firm/
Manufacturer		 Viewray Incorporated
2 Thermo Fisher Way
Oakwood Village OH 44146-6536
For Additional Information Contact Mr. James Talbot
650-252-0949 Ext. 455
Manufacturer Reason
for Recall		 ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
FDA Determined
Cause 2		 Software Design Change
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.
Quantity in Commerce 3
Distribution US Nationwide Distribution in the states of CA, MO & WI
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
-
-