Centricity Universal Viewer with PACS-IW foundation 6 — Class II medical device recall Z-1886-2019
Terminated recall by GE Healthcare, LLC, reported 2019-07-03, distributed nationwide. There is a potential that one or more images or image series may be missing from exams without a warning displ
| Recall number | Z-1886-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-05-17 |
| Classified | 2019-06-26 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2023-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BR, CA, CH, CO, DE, ES, FR, GB, GH, IE, IL, IN, IT, KW, MX, NL, PA, PL, QA, RU, SA, SI, TR, UY, ZA |
| Quantity | 292 units |
| Model numbers | 2090255-001 |
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 for recall
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1886-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.