GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
FDA Recall Z-1488-2014 · Posted 2014-04-23
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIYN
Date Initiated2014-03-27
Date Terminated2015-01-14
Product Quantity447 (81US, 366 OUS)
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.
Firm Action
GE Healthcare sent an "Urgent Medical Device Correction" letter dated March 27, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Managers of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare service representative).
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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