RefleXion X1 Radiotherapy System Recalled for Potential Radiation Dose Error
Reflexion Medical is recalling the RefleXion X1 Radiotherapy System due to a potential dose error affecting patients treated with out-of-session SCINTIX partial fraction therapy. Seven systems were distributed across six U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall without reported illnesses or injuries, meeting the criterion of 'risk-of-harm products where injury has not yet been reported,' which corresponds to High severity.
Plain-English summary
RefleXion Medical, Inc. is recalling the RefleXion X1 Radiotherapy System Model RXM1000 (Software version 2.1.19-3) due to a potential dose error in patients receiving out-of-session SCINTIX partial fraction therapy. This radiotherapy device combines computed tomography detection with linear accelerator capabilities.
Seven systems were distributed in the United States: California, Connecticut, New Jersey, Oregon, Pennsylvania, and Texas. The potential dose error may impact the radiation dose accuracy for patients treated using this specific therapy modality.
The FDA classified this as a Class II recall.
The recalled product
- Product
- RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
- Manufacturer
- Reflexion Medical, Inc.
- Hazard
- Affected units
- 7
Distribution
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