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U.S. Department of Health and Human Services

Class 2 Device Recall GE LOGIQ 9 ultrasound system

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  Class 2 Device Recall GE LOGIQ 9 ultrasound system see related information
Date Initiated by Firm March 22, 2018
Create Date September 06, 2018
Recall Status1 Terminated 3 on August 24, 2021
Recall Number Z-2984-2018
Recall Event ID 80928
510(K)Number K061129  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product GE LOGIQ 9 ultrasound system

Product Usage:

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).
Code Information Each consignee have one serial numbers assigned
Recalling Firm/
Manufacturer		 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
9900 W Innovation Dr
Milwaukee WI 53226-4856
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
FDA Determined
Cause 2		 Component design/selection
Action On March 23, 2018 GE Healthcare sent letters to their consignees informing them about the recall of LOGIQ 9, LOGIQ E9, Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, and Vivid E95 ultrasound systems which have been installed since April 2015 or which have received a power cord replacement since April 2015. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. Your safety and the safety of your patients is of our utmost concern. Safety Issue The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. This can lead to injuries up to and including cardiac arrhythmia or cardiac arrest. A minor injury has been reported as a result of this issue. Safety Instructions You may continue to use your system. If you need to remove the power cord from the rear of the unit (see picture of location below), before doing so be sure to do the following: 1. Turn the system off 2. Unplug it from the wall If the system end of the power cord (see picture below) is damaged, discontinue use of the system until a replacement cord is provided. If you experience any power issues with your unit, discontinue use of the system and contact GEHC Service. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. Contact Information If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS)
Distribution Nationwide and Puerto Rico FOREIGN: Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State of Brazil, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Congo, The Democratic Republic of the Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, The Former Yugoslav Republic of, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = GENERAL ELECTRIC CO.
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