GE Healthcare, LLC recalls Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from…
- Recall date
- December 16, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0819-2020
- FDA classification
- Class II
- Brand / firm
- GE Healthcare, LLC
- Sold / distributed
- Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
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