Device evidence

device-recall:cfres:125267

GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The Cathiab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathiab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: 1) Communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices. 2) Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. 3) Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.

Official recall number

Z-0853-2014

Evidence summary

Product code: IZI
Recall status: Terminated
Event initiated: November 15, 2013
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0853-2014