RefleXion X1 Radiotherapy System Model RXM1000 recall (Reflexion Medical, Inc.)
Medical deviceClass IIOngoing
Summary: Reflexion Medical, Inc. is recalling 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.
What is being recalled
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US: CA, TX, PA, CT, NJ, OR, LA, OH (states named: California, Connecticut, Louisiana, New Jersey, Ohio, Oregon, Pennsylvania, Texas)
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1656-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 9, 2026 |
| Reported | April 8, 2026 |
| Company | Reflexion Medical, Inc. |
| Company location | Hayward, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12 |
More recalls from Reflexion Medical, Inc. · all medical device recalls · recalls from February 2026