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U.S. Department of Health and Human Services

Class 2 Device Recall ViewRay Radiation Therapy System

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  Class 2 Device Recall ViewRay Radiation Therapy System see related information
Date Initiated by Firm January 15, 2015
Date Posted May 05, 2015
Recall Status1 Terminated 3 on September 23, 2015
Recall Number Z-1580-2015
Recall Event ID 71050
510(K)Number K111862  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ViewRay System, Radiation Therapy System
Code Information M/N 10000, S/N 100 only
Recalling Firm/
Manufacturer		 Viewray Incorporated
2 Thermo Fisher Way
Oakwood Village OH 44146-6536
For Additional Information Contact
440-703-3210 Ext. 455
Manufacturer Reason
for Recall		 The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.
FDA Determined
Cause 2		 Software Design Change
Action On January 15, 2014, ViewRay personnel discussed the investigation of the issue (slice mismatch error) with the customer. The firm advised the customer that until the issue was corrected, to not treat patients in non HFS orientations, or to use the MR acquired from the ViewRay system as the primary plan series for non HFS scans. ViewRay installed software version 3.4.5.28 on January 20 and 21, 2014, in order to prevent this slice mismatch error from occurring in any patient position.
Quantity in Commerce 1
Distribution US distribution to MO.
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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