Z-2985-2018Class II

GE Vivid E9 ultrasound system

Name: Z-2985-2018 GE Vivid E9 ultrasound system
Creator: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Published: 2018-03-22
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-03-22 / Terminated / root cause: design

FDA source

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL began a recall of GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended... on 2018-03-22. FDA classified it as Class II and gives the reason as "The system side of the power cord may break and expose the electrical conductors leading to the risk of shock". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2985-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-22
Posted: 2018-09-06
Terminated: 2021-08-24
Recalling firm: GE Healthcare
Product: GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, Testes, thyroid; Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, Thoracic, & vascular)
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Each consignee have one serial numbers assigned

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2985-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2983-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2984-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2985-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2986-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2987-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2988-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2989-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2990-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06

Product code IYN

K131514Class IIGe Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS / cleared 2013-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)