The U.S. Food and Drug Administration (FDA) announced January 12 that GE OEC Medical Systems, Inc., its parent company, the General Electric Company doing business as GE Healthcare, and two of their top executives have signed a consent decree of permanent injunction related to X-ray surgical imaging systems manufactured by GE OEC Medical Systems. The consent decree prohibits the manufacturing and distribution of specified GE OEC Medical Systems X-ray surgical imaging systems at facilities in Salt Lake City, Utah, and Lawrence, Massachusetts, until the devices and facilities have been shown to be in compliance with FDA's current good manufacturing practice (CGMP) requirements as set forth in the Quality System (QS) regulation for devices.

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

The X-ray surgical imaging systems subject to the decree are manufactured and designed at GE OEC Medical Systems' facilities in Salt Lake City, Utah, and Lawrence, Massachusetts, and include the 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, as well as their components and accessories. These are radiological image processing and image-intensified fluoroscopic X-ray systems that are used during diagnostic, surgical, and interventional procedures, such as orthopedic, cardiac, critical-care, emergency room procedures, and other imaging applications.
"These devices are used on thousands of patients, and their dependability and accuracy are critical for the successful outcomes of important medical procedures," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "When FDA's August 2006 inspection found ongoing CGMP deficiencies at the Utah facility, GE voluntarily stopped distributing devices from that facility and is working with FDA to ensure that necessary corrective actions are fully implemented."

FDA's most recent inspection of the Utah facility, conducted between July 31 and August 29, 2006, revealed CGMP deficiencies, including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions. FDA previously inspected the Utah facility between November 15 and December 1, 2004. Following that inspection, FDA issued a Warning Letter on March 31, 2005, citing violations of the CGMP requirements. The government brought this enforcement action when FDA's 2006 inspections showed inadequate responses to FDA's requests for corrections in the 2005 Warning Letter.

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