Centricity Universal Viewer with PACS-IW foundation 6 — Class II medical device recall Z-0375-2019
Terminated recall by GE Healthcare, LLC, reported 2018-11-14, distributed in CA, CO, DE, FL, HI, NY, OK, PA…. Synchronization failure
| Recall number | Z-0375-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-10-11 |
| Classified | 2018-11-02 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2023-03-20 |
| Distributed | CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, WV |
| Countries outside the US | BE, BR, CA, CH, CO, DE, ES, FR, GH, IE, IT, MX, NL, PA, PL, SA, TR, ZA |
| Quantity | 73 |
Product
Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
Reason for recall
Synchronization failure
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-0375-2019. 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.