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GE Healthcare, LLC recalls GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
Recalled April 30, 2014 · FDA recall Z-1488-2014 · GE Healthcare
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. · FDA Class II
Units
447 (81US, 366 OUS)
Sold at
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.
Description
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.
Product
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →