GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled the GE Vivid E9 ultrasound system due to incorrect probe power surveillance settings on four specific probes (C1-5-D, C2-9-D, IC5-9-D, and M5Sc-D). This safety issue may cause these probes to overheat during use. The recall affects 447 systems total—81 distributed in the United States across multiple states including California, Colorado, Georgia, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, Nevada, New Mexico, New York, Ohio, Texas, Virginia, and Wisconsin—and 366 systems distributed internationally across countries including Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, India, Ireland, Italy, Japan, Korea, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, and Taiwan.
Affected consumers can identify their system by checking if their GE Vivid E9 ultrasound system matches any of the specific serial numbers listed in the recall notice. The recall record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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. Quantity: 447 (81US, 366 OUS) Lot/code info: Mfg Lot or Serial # System ID 0000000VE90667 VE9000667 0000000VE90680 VE9000680 0000000VE90878 VE9000878 0000000VE91045 VE9001045 0000000VE91821 VE9001821 0000000VE91826 VE9R001826 0000000VE92470 VE9R002470 0000000VE93780 VE9R003780 0000000VE94119 VE9R004119 0000000VE94120 VE9R004120 0000000VE94291 VE9R004291 0000000VE94521 VE9004521 0000000VE94736 VE9R004736 0000000VE94790 VE9R004790 0000000VE94876 VE9R004876 0000000VE95024 VE9R005024 0000000VE95025 VE9R005025 0000000VE95027 VE9R005027 0000000VE95028 VE9R005028 0000000VE95222 VE9R005222 0000000VE95226 VE9R005226 0000000VE95271 VE9R005271 0000000VE95302 VE9R005302 0000000VE95319 VE9R005319 0000000VE95558 VE9R005558 0000000VE95597 VE9R005597 0000000VE95599 VE9R005599 0000000VE95604 VE9R005604X 0000000VE95654 VE9005654 0000000VE95908 VE9005908 0000000VE95949 VE9005949 0000000VE95960 VE9005960 0000000VE95969 VE9005969 0000000VE96001 VE9006001 0000000VE96004 VE9006004 0000000VE96005 VE9006005 0000000VE96008 VE9006008 0000000VE96009 VE9006009 0000000VE96010 VE9006010 0000000VE96020 VE9006020 0000000VE96022 VE9006022 0000000VE96138 0000000VE96185 VE9006185 0000000VE96186 VE9006186 0000000VE96187 VE9006187 0000000VE96188 VE9006188 0000000VE96189 VE9006189 0000000VE96190 VE9006190 0000000VE96191 VE9006191 0000000VE96193 VE9006193 0000000VE96194 VE9006194 0000000VE96210 VE9006210 0000000VE96211 VE9006211 0000000VE96212 VE9006212 0000000VE96232 VE9006232 0000000VE96233 VE9006233 0000000VE96234 VE9006234 0000000VE96235 VE9006235 0000000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.