Reported Apr 8, 2026 · Ongoing
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Reflexion Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Reflexion Medical, Inc. · 25881 Industrial Blvd · Hayward, CA · 94545-2991
Is this the product you have?
- RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
- Lot codes and dates
- Software Version2.1.29-4
- and Software Version2.1.35-1
- 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
- Amount recalled
- 12
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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