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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Event Detail

Event ID 64762
Product Type Devices
Status Ongoing
Recalling Firm Ge Healthcare It
City Barrington
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Software versions: 3.0.x Class II 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. 53 units Z-0454-2014