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U.S. Department of Health and Human Services

Class 2 Device Recall Treatment Planning and Delivery System Software version 3.6. ViewRay

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  Class 2 Device Recall Treatment Planning and Delivery System Software version 3.6. ViewRay see related information
Date Initiated by Firm May 07, 2015
Date Posted July 02, 2015
Recall Status1 Terminated 3 on February 04, 2016
Recall Number Z-1954-2015
Recall Event ID 71505
510(K)Number K111862  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Treatment Planning and Delivery System Software version 3.6. ViewRay.

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 #'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
Manufacturer Reason
for Recall		 The software was failing to determine new patient locations if imaging is not enabled during treatment.
FDA Determined
Cause 2		 Software design
Action On May 7, 2015 the firm sent Customer Advisory Notification Letters to their customers.
Quantity in Commerce 3
Distribution Distributed 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
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