RefleXion X1 Radiotherapy System recalled for software defect causing misaligned radiation dose delivery
What this means
RefleXion Medical's X1 Radiotherapy System has a software defect that can cause radiation treatment to be delivered to the wrong location when certain positioning corrections are made. This may result in radiation doses being delivered 5mm or more away from the intended target, with possible underdosing of 10% to 20%. The issue affects 12 systems running specific software versions.
- If you operate or manage a RefleXion X1 system, contact RefleXion Medical immediately for a software update
- Do not perform angular roll corrections followed by repeat localization until the fix is applied
- Review recent treatment records to verify positioning accuracy if your system uses affected software versions
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1656-2026Want us to check the next one for you?
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