Centricity PACS-IW with Universal Viewer version 5 — Class II medical device recall Z-1885-2019
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-1885-2019 |
|---|---|
| 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 | 50 units |
| Model numbers | 2068177-001 |
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 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-1885-2019. 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.