Medical device recalls Moderate risk

GE Vingmed Ultrasound As recalls GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA

Recall date
May 2, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2316-2024
FDA classification
Class II
Brand / firm
GE Vingmed Ultrasound As
Sold / distributed
US: IL, MA, NM, NY, OK,

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA

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