GE Healthcare Centricity Universal Viewer Breast Imaging Centricity… — Class II medical device recall Z-0793-2019
Terminated recall by GE Healthcare, LLC, reported 2019-02-13, distributed nationwide. When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed
| Recall number | Z-0793-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2019-02-01 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2021-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BM, BR, CA, CH, CL, CO, DE, ES, FR, GB, GT, IN, IT, KR, KW, KY, LB, MT, MX, MY, PA, RU, SA, SG, TR, VE, ZA |
Product
GE Healthcare Centricity Universal Viewer Breast Imaging 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.
Reason for recall
When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.
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-0793-2019. 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.