Recall database

Fludeoxyglucose F18-Guided Radiation Therapy System recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-1656-2026

Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000

Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to t…

Fludeoxyglucose F18-Guided Radiation Therapy System
Software change control

Reflexion Medical, Inc…CAApr 8, 2026

Class IIOngoingZ-2486-2025

Reflexion Medical, Inc. recalls RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)008…

Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).

Fludeoxyglucose F18-Guided Radiation Therapy System
Software change control

Reflexion Medical, Inc…CASep 10, 2025