Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System
- Recalling company
- Reflexion Medical, Inc.
- Product
- RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
- Reason
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Feb 9, 2026
- Reported
- Apr 8, 2026
- Distribution
- US: CA, TX, PA, CT, NJ, OR, LA, OH
- Status
- Ongoing
- Quantity
- 12
- Lot / codes
- 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.
- Company location
- Hayward, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1656-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1656-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.