Recall Z-1656-2026— Reflexion Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Reflexion Medical, Inc., initiated 2026-02-09. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Reflexion Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-09
- Firm location
- Hayward, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.