Device Recall Innova 2100IQ with InnovaIQ Table Option

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Radiology Devices

2

No

Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.

Innova 2100IQ system with InnovaIQ Table Option || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, || rotational imaging procedures.