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U.S. Department of Health and Human Services

Class 2 Device Recall ViewRay MRIdian

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 Class 2 Device Recall ViewRay MRIdiansee related information
Date Initiated by FirmDecember 24, 2015
Date PostedFebruary 12, 2016
Recall Status1 Terminated 3 on February 22, 2017
Recall NumberZ-0806-2016
Recall Event ID 73086
510(K)NumberK111862 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductMRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Code Information Model #: 10000, Serial #'s: 100, 101, 102, 104 & 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		The system loaded a completion fraction in the incorrect order after a treatment interruption.
FDA Determined
Cause 2		Software design
ActionViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan. While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected with the completion plan. 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 Commerce5 units
DistributionUS Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of 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
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