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
RefleXion Medical is recalling the RefleXion X1 Radiotherapy System Model RXM1000 (Part #800-00006-00) due to a software defect. When angular roll corrections are followed by repeat localization, the corrections are not carried through to treatment delivery, potentially causing radiation dose to be delivered to an incorrect location with a displacement of 5mm or higher and 10–20% underdose.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
- UDI-DI
- 00860003983812, 00860003983812, 00860003983812, 00860003983812, 00860003983812, 00860003983812, 00860003983812, 00860003983812, 00860003983812, 00860003983812, 00860003983812, 00860003983812
Where it was sold
Distributed in California, Connecticut, Louisiana, New Jersey, Ohio, Oregon, Pennsylvania, and Texas.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification