# FDA recall Z-2986-2018

> **GE Medical Systems Ultrasound & Primary Care Diagnostics, LL** · Class II · device recall initiated 2018-03-22.

## Product

GE Vivid E80 ultrasound system    Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, 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; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoracic, & vascular).

## Reason for recall

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

## 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

## Key facts

- **Recall number:** Z-2986-2018
- **Recalling firm:** GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-22
- **Report date:** 2018-09-12
- **Termination date:** 2021-08-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milwaukee, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2986-2018

## Citation

> AI Analytics. FDA recall Z-2986-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2986-2018. Source: US FDA. Licensed CC0.

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