Centricity PACS Foundation Centricity PACS software product is… — Class II medical device recall Z-1911-2019
Terminated recall by GE Healthcare, LLC, reported 2019-07-10, distributed nationwide. There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient
| Recall number | Z-1911-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-05-16 |
| Classified | 2019-07-01 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2023-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CL, DE, ES, FR, GB, IN, IT, JP, KW, LB, SG |
| UPC / GTIN / UDI-DI | 00840682104807 |
| Model numbers | 2098268-001 |
Product
Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
Reason for recall
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
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-1911-2019. 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.