FDA-Device2013-03-20Class II
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
GE Healthcare, LLC
Hazard
A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems.
Sold states
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA, WV, WI and the countries of VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, NORWAY, NIGERIA, NICARAGUA, MOROCCO, MALTA, LEBANON, KAZAKHSTAN, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, FRANCE, EGYPT, CHINA, CANADA, BRAZIL, BELGIUM, and NEW ZEALAND.
Affected count
297
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0947-2013Don't want to check this manually?
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