Centricity Universal Viewer 7 — Class II medical device recall Z-0012-2022
Terminated recall by GE Healthcare, LLC, reported 2021-10-13, distributed in AR, IL, ME, MS, NE, NJ, NY, TN. A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes a
| Recall number | Z-0012-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-08-12 |
| Classified | 2021-10-01 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2024-08-22 |
| Distributed | AR, IL, ME, MS, NE, NJ, NY, TN |
| Countries outside the US | BE, CA, CH, CR, DE, FR, GB, IN, JP, KR, KW, SA, SG, TR |
| Quantity | 49 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840682145794 |
| Model numbers | 5829628-0XX |
Product
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Reason for recall
A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
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-0012-2022. 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.