Official recall notice
FDA Recall: RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
- Recall date
- 2026-04-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
12
Product description
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.