Class 2 Device Recall MRIdian Linac Radiation Therapy System

• Date Initiated by Firm: March 18, 2019
• Create Date: May 02, 2019
• Recall Status: Terminated on June 16, 2022
• Recall Number: Z-1251-2019
• Recall Event ID: 82612
• 510(K)Number: K170751
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: MRIdian Linac Radiation Therapy System, Model 20000.
• Code Information: Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
• Recalling Firm/ Manufacturer: Viewray, Inc.; 815 E Middlefield Rd; Mountain View CA 94043-4025
• For Additional Information Contact: Mr. Sean Delaney; 650-252-0927
• Manufacturer Reason for Recall: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
• FDA Determined Cause: Software design
• Action: An undated letter was issued via email to customers on 3/18/2019, except for one customer who was issued the letter on 3/26/2019.
• Quantity in Commerce: 17 devices
• Distribution: Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, 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