medical Class II Updated 2020-01-29

GE Healthcare, LLC recalls Centricity Universal Viewer 6.0, a device that displays medi

Recalled Product

Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model 2088026-9XX Versions 6.0 SP10 or higher
View official government recall

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