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GE Healthcare, LLC recalls Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from o
Recalled January 29, 2020 · FDA recall Z-0819-2020 · GE Healthcare
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. · FDA Class II
Units
205
Sold at
Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
Description
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.
Product
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →