Centricity Enterprise Archive is a software product for receiving — Class II medical device recall Z-0833-2015
Terminated recall by Ge Healthcare It, reported 2014-12-31, distributed nationwide. GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from
| Recall number | Z-0833-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ge Healthcare It, Barrington, IL, United States |
| Recall initiated | 2013-04-19 |
| Classified | 2014-12-19 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2016-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 115 units |
Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are service personnel and system administrators and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-1 profiles (published by IHE).
Reason for recall
GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.
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-0833-2015. 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.