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U.S. Department of Health and Human Services

Class 2 Device Recall MRIdian ViewRay Radiation Therapy System, ViewRay

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  Class 2 Device Recall MRIdian ViewRay Radiation Therapy System, ViewRay see related information
Date Initiated by Firm August 27, 2015
Date Posted October 09, 2015
Recall Status1 Terminated 3 on June 09, 2017
Recall Number Z-0115-2016
Recall Event ID 72166
510(K)Number K111862  
Product Classification System, radiation therapy, radionuclide - Product Code IYE
Product MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿

Is 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 Numbers: 100, 101, 102, & 105
Recalling Firm/
Manufacturer		 Viewray Incorporated
2 Thermo Fisher Way
Oakwood Village OH 44146-6536
For Additional Information Contact Mr. Garth M. Nobis
650-252-0925
Manufacturer Reason
for Recall		 ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
FDA Determined
Cause 2		 Device Design
Action ViewRay sent an Customer Advisory Notice dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It is recommended that if you have a patient on the couch and you receive the fault ''The patient table has experienced an unintended movement. This may be due to the patient or operator leaning on the table. Clear the fault and retry. If the problem persists call Service" on the TPDS,first attempt to clear the fault. If it does not clear and requires you to restart the couch software (same switch as restarting the RTCS) you should manually remove the patient from the couch before restarting the system. A software patch to address this issue is planned for early 2016. In the meantime please practice our recommendation of removing the patient from the couch prior to restarting the RTCS. 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 Commerce 4 units
Distribution US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
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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