| 2026-02-09 |
Class II
|
Ongoing |
Z-1656-2026 |
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 |
— |
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied i… |
| 2025-07-22 |
Class II
|
Ongoing |
Z-2486-2025 |
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 … |
— |
Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead … |
| 2024-04-16 |
Class II
|
Ongoing |
Z-1933-2024 |
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that comb… |
— |
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. |
| 2021-11-24 |
Class II
|
Terminated |
Z-0470-2022 |
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Del… |
— |
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). |