RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
This recall has been terminated (originally issued November 24, 2021).
- Company
- Reflexion Medical, Inc.
- Recall Initiated
- November 24, 2021
- Terminated
- July 8, 2024
- Recall Number
- Z-0470-2022
- Quantity
- 3 devices
- Firm Location
- Hayward, CA
- Official Source
- View on FDA website ↗
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).
Distribution
U.S. Nationwide distribution in the states of CA and TX
Lot / Code Info
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
Root Cause
Software design
Action Taken
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