FDA-Device2020-01-29Class II
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
GE Healthcare, LLC
Hazard
Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
Sold states
Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
Affected count
205
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0819-2020Don't want to check this manually?
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