by
Barbara Kram, Editor | January 16, 2007
Under the terms of the consent decree, signed by Joseph M. Hogan, Senior Vice President, GE Company 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, 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 FDA that corrections have been made. Manufacturing and distribution can resume at the Utah and Massachusetts facilities once 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 his/her findings to FDA. 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.
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Under the consent decree, the companies are also required to submit to FDA a corrective action plan for bringing into compliance with the 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 U.S. by physicians, hospitals, and other facilities. GE OEC Medical Systems also has voluntarily initiated product recalls on several models of its X-ray surgical imaging systems, and users can contact the company at 1-800-874-7378 (Option 8) for copies of the recall notices.
The consent decree allows the companies to continue to provide routine service maintenance, replacement parts, and accessories for the GE OEC X-ray surgical imaging systems that are already employed in U.S. hospitals and other health care facilities.
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