FDAFDA · Food and drugs·Recall number Z-0819-2020
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Published January 29, 2020 · Recall initiated: December 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
- Lot
- Model 2088026-9XX Versions 6.0 SP10 or higher
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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