Class 2 Device Recall MRIdian & MRIdian Linac Radiation Therapy System

• Date Initiated by Firm: March 03, 2019
• Date Posted: December 12, 2019
• Recall Status: Terminated on April 28, 2021
• Recall Number: Z-0676-2020
• Recall Event ID: 84303
• 510(K)Number: K111862 K170751
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: MRIdian Linac Radiation Therapy System Model 10000 and 20000
• Code Information: Serial Numbers: 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225 Device Listing Number: D158423 and D297999
• Recalling Firm/ Manufacturer: Viewray, Inc.; 815 E Middlefield Rd; Mountain View CA 94043-4025
• For Additional Information Contact: Sean Delaney; 440-703-3210 Ext. 444
• Manufacturer Reason for Recall: Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.
• FDA Determined Cause: Error in labeling
• Action: On 03/03/2019, the firm emailed an "URGENT DEVICE RECALL" to customers to inform them of a safety issue with the Treatment Planning and Delivery System (TPDS) in the MRIdian System. The notice explained that when a partially-completed patient treatment regiment is moved to their system from another system, the use needs to rescale the plan. The TPDS does not automatically rescale the treatment plan. The customers are instructed: If they want to move a treatment plan from one system to another and still show the total original prescribed dose on the MRIdian TPDS the customer will have multiple ways to do this. 1. Once the user/operator has evaluated the plan at the full dose, ensure the prescription matches the dose and number of fractions to be delivered on the MRIdian, and scale the dose to the target by either renormalizing or changing the target objective in the optimizer. 2. Keep the original total number of fractions (including those delivered elsewhere) in the prescription but when the plan is assigned to the fractions in the delivery calendar, Discontinue the number of fractions that have already been delivered on another system. 3. Import the previously delivered dose files as a RTDose and fuse with the plan images. Optimize to the remaining target dose that is to be deliver on MRIdian. Include the imported dose as Previously Delivered Dose and Calculate in the Finish screen to display the full dose which has and will be delivered. Ensure the prescription matches the dose and number of fractions to be delivered on the MRIdian. 4. Import the previously delivered dose files as RTDose and fuse with the plan images. Optimize to the original total dose, including the Previously Delivered Dose as part of the optimization. Ensure the prescription matches the total dose and number of fractions including those treated elsewhere and those to be delivered on the MRIdian. The customer is also informed that the Recalling Firm will address this is
• Quantity in Commerce: 24 Systems
• Distribution: US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE
• 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