Reflexion Medical, Inc.: RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Reflexion Medical, Inc.
- Product
- RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US: CA, TX, PA, CT, NJ, OR, LA, OH
- Recall initiated
- 2026-02-09
- Code info
- 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.
- Product quantity
- 12
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Hayward
- State
- CA
- Country
- United States
- Event id
- 98518
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