Class II

Medical Device Recall: 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

Reflexion Medical, Inc. · April 16, 2024

Reason for Recall

A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.

Product Description

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.

Distribution

U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.

States Affected

CA, CT, NJ, OR, PA, TX

Quantity Affected

7 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1933-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.