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Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Recalled April 8, 2026 · FDA recall Z-1656-2026 · Reflexion Medical
Hazard
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. · FDA Class II
Units
12
Sold at
US: CA, TX, PA, CT, NJ, OR, LA, OH
Description
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.
Product
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Manufacturer(s)
Reflexion Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →