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U.S. Department of Health and Human Services

Class 2 Device Recall Patient Handling System

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 Class 2 Device Recall Patient Handling Systemsee related information
Date Initiated by FirmApril 01, 2015
Date PostedJuly 16, 2015
Recall Status1 Terminated 3 on February 04, 2016
Recall NumberZ-2085-2015
Recall Event ID 71555
510(K)NumberK111862 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductPatient 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 ContactMr. 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
ActionViewRay 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 Commerce3
DistributionUS Nationwide Distribution in the states of CA, MO & WI
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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