FDA Device recall Z-0833-2015
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data by Ge Healthcare It, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0833-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-19 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare It |
| Distribution | US |
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
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.
Identifiers
| code_info | Centricity Enterprise Archive versions: 4.0.x |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0833-2015%22
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