Class 2 Device Recall RefleXion X1 System

• Date Initiated by Firm: November 24, 2021
• Create Date: January 10, 2022
• Recall Status: Terminated on July 08, 2024
• Recall Number: Z-0470-2022
• Recall Event ID: 89212
• 510(K)Number: K190978
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
• Code Information: Model: RXM1000 Serial Numbers/UDI Codes: X11001 / (01)00860003983805(11)210125(21)X11001 X11002 / (01)00860003983805(11)210324(21)X11002 X11003 / (01)00860003983805(11)210524(21)X11003
• Recalling Firm/ Manufacturer: Reflexion Medical, Inc.; 25881 Industrial Blvd; Hayward CA 94545-2991
• For Additional Information Contact: John Fiducia; 650-263-8888
• Manufacturer Reason for Recall: Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
• FDA Determined Cause: Software design
• Action: On 11/24/2021 and 12/02/2021, the firm emailed customers to inform them of an ongoing investigation a potential dose discrepancy while treating patients in an orientation other than Head First Supine (HFS), i.e., Feet First Supine (FFS) and Head First Prone (HFP) and Feet First Prone (FFP). On 12/22/2021, the firm sent an "Urgent Safety Notification" letter to customers informing them that the Recalling Firm has confirmed that a dose discrepancy exists for patients treated in any orientation other than Head First Supine (HFS). Customers are instructed, until the updated software is install at their institution, the Recalling Firm recommends using only the HFS orientation when treating patients on the affected systems. It is estimated that a software updated to address the issue will be installed at all sites by mid to late January 2022. For questions, contact the Senior Director of Technical Support at 650-263-8888 or email support@reflexion.com
• Quantity in Commerce: 3 devices
• Distribution: U.S. Nationwide distribution in the states of CA and TX
• 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