Class 2 Device Recall MRIdian Linac Systems

• Date Initiated by Firm: November 18, 2019
• Create Date: April 27, 2020
• Recall Status: Terminated on February 22, 2023
• Recall Number: Z-1803-2020
• Recall Event ID: 85441
• 510(K)Number: K111862 K170751
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
• Code Information: Model No.10000 - Serial No's:. 100,104,105,112,113 Model No. 20000 - Serial No's: 101,102,107,108,200,201,203,204,206,207,209,211, 213,214,215,216,217,218,221,223,225,227,228,232,238,240,243, 244,247,250
• Recalling Firm/ Manufacturer: Viewray, Inc.; 815 E Middlefield Rd; Mountain View CA 94043-4025
• For Additional Information Contact: Sean Delaney; 650-252-0927
• Manufacturer Reason for Recall: Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
• FDA Determined Cause: Software design
• Action: On 11/18/2019, the firm send an "Urgent Device Correction" letter to customers via email to inform them firm has become aware of an issue impacting the MRIdian System Treatment Planning and Delivery System (TPDS) software. The issue relates to an optional feature related to using previously delivered dose to make a new plan on MRIdian. The firm determined that in some cases dose previously delivered to a patient may not be accurately registered with a daily scan. The firm is instructing its customers to: 1) Do not: Sum previously delivered treatment plans in the treatment delivery workflow as it could result in delivery of a higher or lower dose. 2) Do not: proceed with plan summation if this issue is observed in planning workflow. 3) Do: contact ViewRay Customer Support for assistance when summing plans in the treatment planning workflow. ViewRay is developing a resolution for this issue. You will be contacted by VewRay Customer Support when a software resolution is available. If you have any questions, please do not hesitate to contact ViewRay Customer Support at support@viewray.com or call +1 855-286-8875.
• Quantity in Commerce: 32
• Distribution: Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributors are assigned to applicable regions. Firm send the Urgent Device Corrections to them and they forwarded them to the sites.
• 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