RefleXion X1 Radiotherapy System Model RXM1000
RefleXion X1 Radiotherapy System Model RXM1000 recalled for software defect causing incorrect radiation dose delivery.
Contact RefleXion Medical immediately if you operate or manage this system. Do not perform angular roll corrections followed by repeat localization until the software update is applied. Verify with the manufacturer that your system has received the corrective software patch before resuming affected procedures.
Why it was recalled
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.
How to identify it
UPC 00860003983812 00860003983812 00860003983812 00860003983812 00860003983812 00860003983812 00860003983812 00860003983812
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Where it was sold
Distributed in US-CA, US-CT, US-LA, US-NJ, US-OH, US-OR, US-PA, US-TX.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification