← All recalls
Medical Device

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

Recall date: 2026-04-08 · Source: FDA_DEVICE
Brand / Firm
Reflexion Medical, Inc.
Product
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
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.
Units affected
12
Description
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
View official recall notice →