FDA-Device2026-04-08Class II

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

Reflexion Medical, Inc.

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.

Sold states

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

Affected count

Manufactured in

25881 Industrial Blvd, Hayward, CA, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1656-2026

Original summary

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 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. Software Version: 2.1.29-4 and Software Version: 2.1.35-1. UDI: (01)00860003983812(11)230504(21)X11001, (01)00860003983812(11)230518(21)X11002, (01)00860003983812(11)230505(21)X11003, (01)00860003983812(11)230530(21)X11004, (01)00860003983812(11)230811(21)X11006, (01)00860003983812(11)230410(21)X11007, (01)00860003983812(11)230803(21)X11008, (01)00860003983812(11)240528(21)X11009, (01)00860003983812(11)240820(21)X11010, (01)00860003983812(11)241107(21)X11011, (01)00860003983812(11)241206(21)X11012, (01)00860003983812(11)250731(21)X11013. Distribution: US: CA, TX, PA, CT, NJ, OR, LA, OH Affected quantity: 12

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