WAUKESHA, WISC, JANUARY 12, 2007 - GE Healthcare announced today that it has reached an agreement on a consent decree with the U.S. Food and Drug Administration (FDA) regarding the Company’s OEC Salt Lake City and Lawrence facilities. 

The agreement is limited to GE Healthcare’s GE OEC Medical Systems, Inc., Salt Lake City, Utah, and Lawrence, Massachusetts, facilities and OEC surgical imaging products originating at those sites, including OEC’s 9900 Elite C-Arm System, 9900 Elite NAV C-Arm System, 9800 C-Arm System, 2800 UroView System, 6800 MiniView System, Insta-Trak 3500 NAV System, and ENTrak 2500 NAV System. Under the consent decree, GE Healthcare agrees not to resume manufacturing and distribution of these products in the United States until it completes certain steps, which principally include:

• Obtaining FDA approval of GE Healthcare’s plan to resolve issues with certain products, specifically, the OEC 9900 Elite C-Arm Systems, the OEC 9900 Elite NAV C-Arm Systems, and the OEC 9800 C-Arm Systems currently in use in the U.S.   Installed OEC surgical imaging systems can continue to be used consistent with their intended uses and labeling, and any recently issued recall notices that apply.
• Having an independent third party auditor undertake a review of GE OEC Medical Systems’ Salt Lake City and Lawrence facilities and certify compliance with the FDA’s Quality System regulations and reporting requirements.
• Establishing, to FDA’s satisfaction, that GE OEC processes, facilities and controls are in compliance with these requirements.

Routine service activities by GE OEC are continuing in accordance with the Consent Decree’s terms.

“Patient safety and quality continue to be our top priorities,” said Pete McCabe, president and CEO, Surgery, GE OEC Medical Systems.  “We are committed to providing our customers and their patients with products that are safe and effective for their intended uses, and to follow FDA requirements and guidance on how this can be best achieved.”

The  consent decree arises out of several FDA inspections at OEC facilities in the United States in November 2004 and August, November and December 2006, in which the FDA investigators made a number of observations relating to non-conformities in GE OEC Medical Systems’ Quality System practices and reporting activities.  In connection with the inspections, GE OEC Medical Systems voluntarily ceased shipments of products until the company's processes have been re-validated to ensure compliance with FDA requirements.  GE Healthcare has taken the FDA inspectional observations very seriously and continues to work aggressively to address and resolve the issues identified as quickly as possible, and to improve OEC’s entire quality system.

The consent decree was filed today in the U.S. District Court for the District of Utah and is subject to that court’s approval.
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