FDA-Device2014-04-30Class II
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
GE Healthcare, LLC
Hazard
GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.
Sold states
USA Nationwide Distribution in the states of: CA, CO EL, GA, IN, KS, KY , LA, MA, MI, MO, MT, NY, NM, NV, US: OH, TX, VA, WI. OUS: ARABIC EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, COLOMBIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, INDIA,IRELAND, ITALY, JAPAN, KOREA, NETHERLAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN.
Affected count
447 (81US, 366 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2014Don't want to check this manually?
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