Device Recall Optima IGS 320

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Radiology Devices

2

No

Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Martinique , Morocco, Poland, Republic of Moldova, Russia, Spain Thailand, Trinidad, Turkey, and Uzbekistan.

GE Healthcare Optima IGS 320. || 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.