Home / Recalls / GE Medical Systems Ultrasound & Primary Care Diagnostics, LL / Z-2985-2018

Z-2985-2018 Class II Terminated

Recalled by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL — Milwaukee, WI

Recall Details

Product Type
Devices
Report Date
September 12, 2018
Initiation Date
March 22, 2018
Termination Date
August 24, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,426 (4,717 US; 7,709 OUS ALL PRODUCTS)

Product Description

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)

Reason for Recall

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

Distribution Pattern

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

Code Information

Each consignee have one serial numbers assigned

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  • Z-2986-2018 Class II — GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is gen (March 22, 2018)
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  • Z-2990-2018 Class II — GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ul (March 22, 2018)
  • Z-2988-2018 Class II — GE Vivid E95 ultrasound system Product The device is intended for use by a qu (March 22, 2018)
  • Z-1393-2018 Class II — GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Nu (March 16, 2018)
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