Device evidence

device-recall:cfres:166957

Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Official recall number

Z-3222-2018

Evidence summary

Product code: IZI
Recall status: Terminated
Event initiated: July 16, 2018
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-3222-2018