Device evidence

device-recall:cfres:162606

AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Official recall number

Z-1150-2018

Evidence summary

Product code: JAA
Recall status: Terminated
Event initiated: January 05, 2018
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1150-2018