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U.S. Department of Health and Human Services

Class 2 Device Recall MRIdian Linac System

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  Class 2 Device Recall MRIdian Linac System see related information
Date Initiated by Firm October 20, 2020
Create Date November 20, 2020
Recall Status1 Terminated 3 on October 13, 2023
Recall Number Z-0481-2021
Recall Event ID 86661
510(K)Number K111862  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI.

The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Code Information All Lots/Serial Numbers
Recalling Firm/
Manufacturer		 Viewray, Inc.
815 E Middlefield Rd
Mountain View CA 94043-4025
For Additional Information Contact ViewRay Customer Support
1855-286-8875
Manufacturer Reason
for Recall		 There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
FDA Determined
Cause 2		 Device Design
Action On 10/20/2020, the firm, ViewRay, Inc, emailed an "Urgent Device Correction" notification to all affected consignees. In addition to informing consignees about the correction, the firm asked consignees to take the following actions.: 1. For Customer using TPDS software ver. 5.2.5 or earlier with optional 3 Plane imaging: - Do: Maintain a distance of at least 5 cm (~2) between the receive coil and the inner surface of the bore wall when using 3 Plane cin¿ treatment imaging (Figure 3 & 4). - Do Not: Select 3 Plane cin¿ treatment imaging if a distance of at least 5 cm (~2) cannot be maintained between the receive coil and the inner surface of the bore wall during treatment. 2. For Customer Using TPDS software ver. 5.3 or later with optional 8 fps enabled: - Do Not: Use 8 fps cin¿ treatment imaging until further guidance is provided by ViewRay. - Do: Use 4 fps cin¿ treatment imaging when treating a patient. 3. If you have any questions related to this letter, please contact ViewRay Customer Support at support@viewray.com or call +1 855-286-8875.
Quantity in Commerce 3 systems
Distribution Worldwide Distribution: US (nationwide) to states of: CA, NY, FL, IL, MI, MO, OR, WI and OUS countries of: France, Germany, Italy, United Kingdom, Taiwan, Netherlands, Israel, and Denmark.
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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