FDA DevicesClass II
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Published: April 8, 2026Recall ID: Z-1656-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Additional Source Details
| Field | Value |
|---|---|
| City | Hayward |
| State | CA |
| Event id | 98518 |
| Address 1 | 25881 Industrial Blvd |
| 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. |
| Postal code | 94545-2991 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 12 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260209 |
| Center classification date | 20260327 |
Overview
- Recalling FirmReflexion Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS: CA, TX, PA, CT, NJ, OR, LA, OH