Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

Recall date

February 9, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1656-2026

FDA classification

Class II

Brand / firm

Reflexion Medical, Inc.

Sold / distributed

US: CA, TX, PA, CT, NJ, OR, LA, OH

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00