| Class 2 Device Recall GE Ultrasound Vivid E9 | |
Date Initiated by Firm | March 27, 2014 |
Date Posted | April 23, 2014 |
Recall Status1 |
Terminated 3 on January 14, 2015 |
Recall Number | Z-1488-2014 |
Recall Event ID |
67905 |
510(K)Number | K131514 |
Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
|
Product | GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging. |
Code Information |
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0000000VE96333 529230US13 0000000VE96439 707220US05 0000000VE96672 850010US07 0000000VE96702 506463US03 0000000VE96808 534551US02 0000000VE96815 527356US02 0000000VE94534 853380306 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact | Local GE Healthcare Service Rep. 262-513-4122 |
Manufacturer 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. |
FDA Determined Cause 2 | Software design |
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). |
Quantity in Commerce | 447 (81US, 366 OUS) |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = IYN
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