FDA Device recall Z-1886-2019
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer i…
- FDA Device
- Class II
- terminated
- Published 2019-07-03
On 2019-07-03 the FDA classified a Class II recall of Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer i… by Ge Healthcare, citing there is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1886-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-17 |
| Published | 2019-07-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.
Reason
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
Identifiers
| code_info | Product ID numbers: 102123-1-Centricity Universal Viewer-00558570 102123-1-Centricity Universal Viewer-02157634 2049…Product ID numbers: 102123-1-Centricity Universal Viewer-00558570 102123-1-Centricity Universal Viewer-02157634 2049-1-Centricity Universal Viewer-00558112 1011-1-Centricity Universal Viewer-00558109 1011-1-Centricity Universal Viewer-02097166 1011-1-Centricity Universal Viewer-02097165 4413-2-Centricity Universal Viewer-01300927 4413-2-Centricity Universal Viewer-01300929 101171-1-Centricity Universal Viewer-02288391 104535-4-Centricity Universal Viewer-01806096 104535-4-Centricity Universal Viewer-01806096 4406-1-Centricity Universal Viewer-00558683 4406-1-Centricity Universal Viewer-00558683 4446-2-Centricity Universal Viewer-00558643 4415-1-Centricity Universal Viewer-00558359 4415-1-Centricity Universal Viewer-01973510 4491-1-Centricity Universal Viewer-00558690 100256-1-Centricity Universal Viewer-00558700 100256-1-Centricity Universal Viewer-01810788 104287-2-Centricity Universal Viewer-00555505 4318-1-Centricity Universal Viewer-00558703 4048-1-Centricity |
|---|
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-1886-2019%22
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