Recall Z-2739-2016— Ge Healthcare It

Class II FDA medical device recall by Ge Healthcare It, initiated 2012-11-16, terminated 2017-01-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. 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 other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users 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-I profiles (published by IHE).. Reason: There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned..

Recalling firm

Ge Healthcare It

Classification

Class II

Status

Terminated

Initiated

2012-11-16

Terminated

2017-01-11

Firm location

Barrington, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.