Z-0819-2020 Class II Terminated
FDA device recall Z-0819-2020 was initiated by GE Healthcare, LLC on December 16, 2019 and is designated Class II. Reason for recall: 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 pote… The recall status is terminated (terminated October 5, 2023). Affected quantity: 205.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2020
- Initiation Date
- December 16, 2019
- Termination Date
- October 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 205
Product Description
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Reason for Recall
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.
Distribution Pattern
Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
Code Information
Model 2088026-9XX Versions 6.0 SP10 or higher