Company: GE Healthcare It
Date of Enforcement Report: 12/11/2013
Class lI:

PRODUCT

The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols. Recall Number Z-0454-2014

REASON
GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive, and the WADO protocol is used to retrieve images via Centricity Web from the Enterprise Archive, all images in the exam are returned, including any rejected images. These rejected images are not identifiable as such. A rejected image may result in a misdiagnosis.

RECALLING FIRM/MANUFACTURER
GE Healthcare It, Barrington, IL on 4/19/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
53 units

DISTRIBUTION
Nationwide

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