FDA Enforcement
Class II
Terminated
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Recall: Z-0470-2022
·
Reported January 19, 2022
Enforcement
- Recall Number
- Z-0470-2022
- Event ID
- 89212
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Reflexion Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- January 19, 2022
- Initiation Date
- November 24, 2021
- Classification Date
- January 10, 2022
- Termination Date
- July 8, 2024
- Address
- 25881 Industrial Blvd, N/A, Hayward, CA, 94545-2991, United States
Description
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Reason
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).
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
Distribution
U.S. Nationwide distribution in the states of CA and TX
Quantity
3 devices