Reflexion Medical, Inc. FDA Recalls

4 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00Class IIFeb 9, 2026Due to a radiotherapy medical system software defect, when p	Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a r	Class IIDevices	Feb 9, 2026
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 Class IIJul 22, 2025Due to incorrect software configuration that potentially all	Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour p	Class IIDevices	Jul 22, 2025
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combClass IIApr 16, 2024A potential dose error exists for patients treated with an o	A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.	Class IIDevices	Apr 16, 2024
RefleXion Medical Radiotherapy System - System Label: "* refleXion REF RXM1000 *" Physics Guide/Treatment DelClass IINov 24, 2021Due to dose discrepancy when delivering a plan to a patient	Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation speci	Class IIDevices	Nov 24, 2021