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REFLEXION MEDICAL, INC.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Reflexion Medical Radiotherapy System	RXM1000	FDA UDI	Class II	Active
RefleXion Medical Radiotherapy System	RXM1000	FDA UDI	Class II	Active
RefleXion Medical Radiotherapy System	K190978	FDA 510(k)	Class II	Active
RefleXion Medical Radiotherapy System (RMRS)	DEN220014	FDA 510(k)	Class II	Active
RefleXion Medical Radiotherapy System, Reflexion X2	K252071	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 9, 2026	Z-1656-2026	—	open, classified	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 treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
Jul 22, 2025	Z-2486-2025	—	open, classified	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).
Apr 16, 2024	Z-1933-2024	—	open, classified	A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Nov 24, 2021	Z-0470-2022	—	terminated	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).