Device evidence

device-recall:cfres:142642

MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.

Official recall number

Z-1244-2016

Evidence summary

Product code: IYE
Recall status: Terminated
Event initiated: December 15, 2015
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1244-2016