Ge Healthcare It recalls Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices

Recalled December 31, 2014 · FDA recall Z-0833-2015 · Ge Healthcare It

Hazard

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. · FDA Class II

Units

115 units

Sold at

Nationwide Distribution including AZ, OH, WA.

Description

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.

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).

Manufacturer(s)

Ge Healthcare It

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →