FDA recall, , Moderate risk
RefleXion X1 Radiotherapy System
The RefleXion X1 Radiotherapy System has a software defect that can deliver the treatment dose to an incorrect location.
Summary by Recall Canary from the FDA notice
What happened
Reflexion Medical, Inc. of Hayward, California recalled the Reflexion X1 Radiotherapy System Model RXM1000, Part #800-00006-00, due to a software defect.
The 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.
The recall began February 9, 2026, and was added to the FDA's Enforcement Report on March 27, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
RefleXion X1 Radiotherapy System
- Model number
- RXM1000
- Part #800-00006-00
- UDI-DI
- 00860003983812
Recall details
- Company began the recall
- Company
- Reflexion Medical, Inc.Hayward, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98518
- Recall number
- Z-1656-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
