GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound

Recalled September 12, 2018 · FDA recall Z-2983-2018 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Hazard

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

Units

12,426 (4,717 US; 7,709 OUS ALL PRODUCTS)

Sold at

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

Description

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

Product

GE LOGIQ E9 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).

Manufacturer(s)

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →