CLASS II Device recall · Reported 12 Sep 2018 · FDA Enforcement Report

GE Vivid 7 ultrasound system recalled by GE Medical Systems Ultrasound

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL is recalling GE Vivid 7 ultrasound system, distributed nationwide in the US. The recall was initiated on 22 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesEach consignee have one serial numbers assigned

Quantity recalled12,426 (4,717 US; 7,709 OUS ALL PRODUCTS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2989-2018
FDA event ID: 80928
Recalling firm: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, Milwaukee, WI
Classification: Class II
Status: Terminated
Recall initiated: 22 Mar 2018
FDA classified: 6 Sep 2018
Reported: 12 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

22 Mar 2018	Recall initiated by company
6 Sep 2018	Classified by FDA	+168 days
12 Sep 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; 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; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Is GE Vivid 7 ultrasound system recalled?

Yes. GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalled GE Vivid 7 ultrasound system on 22 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-2989-2018.

Why was it recalled?

The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

Which lots are affected?

Each consignee have one serial numbers assigned

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

All 12

Reported	Class	Recall	Company	Reason	Where
12 Sep 2018Device	CLASS II	GE Logiq 9 ultrasound system recalled by GE Medical Systems Ultrasound	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide
12 Sep 2018Device	CLASS II	GE Vivid E9 ultrasound system recalled by GE Medical Systems Ultrasound	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide
12 Sep 2018Device	CLASS II	GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 recalled	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide
12 Sep 2018Device	CLASS II	GE Vivid E95 ultrasound system Product The device is recalled	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide
12 Sep 2018Device	CLASS II	GE Logiq E9 ultrasound system recalled by GE Medical Systems Ultrasound	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide

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