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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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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