Centricity Universal Viewer — Class II medical device recall Z-1533-2021
Terminated recall by GE Healthcare, LLC, reported 2021-05-12, distributed nationwide. When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager op
| Recall number | Z-1533-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-03-19 |
| Classified | 2021-05-05 |
| Reported by FDA | 2021-05-12 |
| Terminated | 2023-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 112 units |
| UPC / GTIN / UDI-DI | 00840682145794 |
| Serial numbers | 105906-2-CENTRICITY |
Product
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Reason for recall
When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s).
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-1533-2021. 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.