GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 recall
GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging.…
Why was GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 recalled?
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Each consignee have one serial numbers assigned
- Product
- GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging.…
- Recalling firm
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
- Quantity
- 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS)
- 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, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam
- Recall date
- September 12, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)