Medical Device Recall: RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Reflexion Medical, Inc. · February 9, 2026
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
US: CA, TX, PA, CT, NJ, OR, LA, OH
States Affected
CA, CT, LA, NJ, OH, OR, PA, TX
Quantity Affected
12
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1656-2026
Status: ongoing
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