FDA-Device2013-03-20Class II
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
GE Healthcare, LLC
Hazard
Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.
Sold states
Worldwide Distribution-USA including the states of FL, IL, IN, NJ, NC, OK, TX, and WI, and the countries of UNITED KINGDOM, TUNISIA, SERBIA, RUSSIAN FEDERATION, NORWAY, NIGERIA, LITHUANIA, LEBANON, KOREA, REPUBLIC OF KOREA, ITALY, INDONESIA, INDIA, FRANCE, FINLAND, COLOMBIA, CHINA, and BRAZIL.
Affected count
48
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0934-2013Don't want to check this manually?
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