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Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that comb
Recalled June 5, 2024 · FDA recall Z-1933-2024 · Reflexion Medical
Hazard
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. · FDA Class II
Units
7 systems
Sold at
U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
Description
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
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(s)
Reflexion Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →