FDA-Device2024-07-17Class II
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
GE Vingmed Ultrasound As
Hazard
GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.
Sold states
US: IL, MA, NM, NY, OK,
Affected count
7 units
Manufactured in
Strandpromenaden 45, N/A, Horten, N/A, Norway
Products
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2316-2024Don't want to check this manually?
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