Reflexion Medical recalls
4 official recalls and safety alerts involving Reflexion Medical since 2022-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Reflexion Medical or the relevant agency.
- 2026-04-08
USReflexion Medical, Inc. recalls 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 in the initial localization scan are not carried through to…
- 2025-09-10
- US
Reflexion Medical, Inc. recalls 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 to adverse events (toxicity).
FDA · DeviceReflexion Medical, Inc.U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.Official notice → - 2024-06-05
- US
Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the…
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
- 2022-01-19
- US
Reflexion Medical, Inc. recalls RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User…
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 · DeviceReflexion Medical, Inc.U.S. Nationwide distribution in the states of CA and TXOfficial notice →