FDA Device recall Z-1656-2026
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 by Reflexion Medical, citing 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 local….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1656-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-09 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Reflexion Medical |
| Distribution | CA, CT, LA, NJ, OH, OR, PA, TX |
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.
Identifiers
| code_info | Software Version: 2.1.29-4 and Software Version: 2.1.35-1. UDI: (01)00860003983812(11)230504(21)X11001, (01)00860003983…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1656-2026%22
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