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Z-2987-2018 Class II Terminated

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

FDA device recall Z-2987-2018 was initiated by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL on March 22, 2018 and is designated Class II. Reason for recall: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. The recall status is terminated (terminated August 24, 2021). Affected quantity: 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS).

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 E90 ultrasound system Product Usage: 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 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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