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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity Web

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 Class 2 Recall
GE Centricity Web
see related information
Date Posted December 05, 2013
Recall Status1 Open
Recall Number Z-0454-2014
Recall Event ID 64762
Product Classification System, Digital Image Communications, Radiological - Product Code LMD
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.
Code Information Software versions: 3.0.x
Recalling Firm/
Manufacturer
Ge Healthcare It
540 W Northwest Hwy
Barrington, Illinois 60010-3051
For Additional Information Contact GE Healthcare Remote Online Center
800-437-1171
Manufacturer Reason
for Recall
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, an
FDA Determined
Cause 2
DESIGN: Software Design
Action Urgent Medical Device Correction letters dated April 19, 2013 were sent to customers. The letter requests that customers ensure that their system is configured to disable the WADO interface using the included instructions until the software revision can be installed at their site. The letter further informs customers that updated software will be sent to them for installation.The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI# 85206R.
Quantity in Commerce 53 units
Distribution US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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