- Recalling firm
- Reflexion Medical, Inc.
- 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.
- Distribution pattern
- US: CA, TX, PA, CT, NJ, OR, LA, OH
- State
- CA
- Status
- Ongoing
- Recall number
- Z-1656-2026
- Recall initiated
- February 9, 2026