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General Electric’s (GE’s) OEC Medical Systems Inc., its parent company—the
GE Co. 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 and Lawrence, Mass., until the devices and facilities have been shown to
be in compliance with the Food and Drug Administration’s current Good Manufacturing
Practice (cGMP) requirements as set forth in the Quality System (QS) regulation
for devices.
The decree was filed in January 2007 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 and Lawrence, Mass., and include the
The radiological image processing and image-intensified fluoroscopic X-ray systems are used during diagnostic, surgical, and interventional procedures, such as orthopedic, cardiac, critical-care, and 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,” says Daniel Schultz, M.D., director of the 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.”
The FDA’s most recent inspection of the Utah facility was conducted between July 31, 2006, and Aug. 29, 2006. It 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.
The FDA previously inspected the Utah facility between Nov. 15, 2004, and Dec. 1, 2004. After that inspection, the FDA issued a Warning Letter on March 31, 2005, citing violations of the cGMP requirements. The government brought this enforcement action when the FDA’s 2006 inspections showed inadequate responses to the FDA’s requests for corrections in the 2005 Warning Letter.
Joseph M. Hogan, senior vice president, GE Co., and president and chief executive officer, GE Healthcare, and Peter McCabe, president and chief executive officer of GE OEC Medical Systems and GE Healthcare Surgery, signed the consent degree. Under its terms, the companies have agreed to take necessary measures to ensure that the X-ray surgical imaging systems manufactured and designed at the Utah and Massachusetts facilities comply with cGMP requirements, as well as FDA regulations for reporting adverse events and malfunctions and device corrections and removals.
The decree also requires that the companies hire an independent expert to conduct inspections of GE OEC Medical Systems’ facilities in Utah and Massachusetts and certify to the FDA that corrections have been made. Manufacturing and distribution can resume at the Utah and Massachusetts facilities once the FDA is satisfied that those facilities are in compliance with the law. An outside expert also will conduct yearly audit inspections for four years to assure that the facilities remain in compliance and will submit those findings to the agency.
The FDA may order the companies to stop manufacturing and distributing the X-ray imaging systems if they fail to comply with any provision of the consent decree, the Federal Food, Drug, and Cosmetic Act, or FDA regulations.
Under the consent decree, the companies also are required to submit to the FDA a corrective action plan for bringing into compliance with the FD&C Act the 9900 Elite C-Arm Systems, the 9900 Elite NAV C-Arm Systems, and the 9800 C-Arm Systems that are currently in use in the United States by physicians, hospitals, and other facilities.
Press Release on GE, FDA Consent Agreement