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U.S. Department of Health and Human Services

Class 2 Device Recall ViewRay Treatment Planning and Delivery System

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  Class 2 Device Recall ViewRay Treatment Planning and Delivery System see related information
Date Initiated by Firm May 04, 2021
Create Date June 09, 2021
Recall Status1 Terminated 3 on October 19, 2023
Recall Number Z-1836-2021
Recall Event ID 87865
510(K)Number K102915  K181989  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.
Code Information French version of the TDS software affected serial numbers: 214, 215, 226 and 240   German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244 
Recalling Firm/
Manufacturer		 Viewray, Inc.
815 E Middlefield Rd
Mountain View CA 94043-4025
For Additional Information Contact ViewRay Customer Support
1855-286-8875 Ext. 444
Manufacturer Reason
for Recall		 Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
FDA Determined
Cause 2		 Software design
Action On May 2021, ViewRay issued an "Urgent Medical Device Correction" notification to all affected consignees via E-Mail. All affected consignees were outside of the US. In addition to informing consignees about the recall, ViewRay asked customers to take the following actions: 1. We will provide an update to customers when new information is available. Until that time: 2. Customers should be aware of these software anomalies and the behavior of the system described in this letter. 3. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification. 4. Any device-related incidents should be reported to ViewRay, ViewRays distributor or local representative. Adverse reactions or quality problems experienced with the use of this product may be reported to the Competent Authority if appropriate or to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 5. If you have any questions related to this letter, please contact ViewRay Customer Support at support@viewray.com or call +1 855-286-8875 toll free 24 hours a day, 7 days a week.
Quantity in Commerce 8 versions
Distribution International distribution only to the countries of France, Germany, Italy, and Switzerland.
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 = MUJ and Original Applicant = VIEWRAY INCORPORATED
510(K)s with Product Code = MUJ and Original Applicant = ViewRay, Incorporated
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