FDA Device recall Z-1885-2019
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that…
- FDA Device
- Class II
- terminated
- Published 2019-07-03
On 2019-07-03 the FDA classified a Class II recall of Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that… 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-1885-2019 |
| 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 PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
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: 4405-1-Centricity Universal Viewer-00558662 4410-1-Centricity Universal Viewer-00558656 9789-1-C…Product ID numbers: 4405-1-Centricity Universal Viewer-00558662 4410-1-Centricity Universal Viewer-00558656 9789-1-Centricity Universal Viewer-00558645 4408-1-Centricity Universal Viewer-00558664 4284-1-Centricity Universal Viewer-00558672 4407-1-Centricity Universal Viewer-00558652 4407-1-Centricity Universal Viewer-00558657 10227-1-Centricity Universal Viewer-00558665 9768-1-Centricity Universal Viewer-00558661 9768-1-Centricity Universal Viewer-01972254 100019-1-Centricity Universal Viewer-00558666 1045-1-Centricity Universal Viewer-00558651 101725-2-Centricity Universal Viewer-00558642 104249-1-Centricity Universal Viewer-00558667 102406-2-Centricity Universal Viewer-00558669 100064-1-Centricity Universal Viewer-00558572 102062-1-Centricity Universal Viewer-00558650 100722-1-Centricity Universal Viewer-02205220 100862-1-Centricity Universal Viewer-01444483 101272-1-Centricity Universal Viewer-00558671 4705-1-Centricity Universal Viewer-00558663 100092-1-Centri |
|---|
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-1885-2019%22
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