FDA-Device2021-08-04Class II
OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
GE OEC Medical Systems, Inc
Hazard
There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of CA, PA, WA, OH, LA, MS, AL, FL, MO, OK, AZ, NJ, CO, MI, NV, MN, KS, TN, NC, IL, MD, SC,GA, UT, WI, MT, AR, WV, ID,CT, IA, WY, VT, KY, DC, SD,ME, Virgin Islands and the countries of Colombia, Egypt, Peru, Chile, Spain, France, Germany, Hong Kong, Canada, Japan, Brazil, Turkey, United Arab Emirates, Singapore, Australia, Thailand, United Kingdom, Italy, Korea, Russia, CHINA, Romania, Nigeria, Czechia, Argentina, Taiwan, Bangladeh, Malaysia, Bosnia and Herzegovina, Poland, Belgium, Indonesia, Dominican Republic, Switzerland, Hungary, New Zealand, Vietnam, Mexico, India, Norway, Philippines, Ecuador, Lithuania, HONDURAS, Uruguay, Sweden, Croatia, Jamaica, Kuwait, Ethiopia, Saudi Arabia, Finland, Bahamas, Trinidad and Tobago, Pakistan, Slovakia, Costa Rica, Israel, Panama, Greece, South Africa and DENMARK.
Affected count
3570 units
Manufactured in
384 N Wright Brothers Dr, N/A, Salt Lake City, UT, United States
Products
OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2161-2021Don't want to check this manually?
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