Device evidence

device-recall:cfres:207500

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.

Official recall number

Z-1933-2024

Evidence summary

Product code: QVA
Recall status: Open, Classified
Event initiated: April 16, 2024
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1933-2024