FDA Device recall Z-0819-2020
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare inf…
- FDA Device
- Class II
- terminated
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare inf… by Ge Healthcare, citing centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0819-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-16 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
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.
Identifiers
| code_info | Model 2088026-9XX Versions 6.0 SP10 or higher |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0819-2020%22
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