Device product
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Z-0819-2020
Product summary
- Event
- Event 84584
- Status
- Terminated
- Classification
- Class II
- Quantity
- 205
- Official record key
device-enforcement:Z-0819-2020
Official wording
Reason: 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.
Code information: Model 2088026-9XX Versions 6.0 SP10 or higher
Distribution pattern: Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
Derived failure modes
-
Unknown
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.