FDAnews Device Daily Bulletin

GE OEC MEDICAL SYSTEMS SIGNS CONSENT DECREE WITH FDA TO CORRECT CGMP LAPSES

Jan. 17, 2007
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GE OEC Medical Systems, its parent company, General Electric -- 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, the FDA announced.

The decree was filed Jan. 12 in the U.S. District Court for the District of Utah and is subject to court approval.

The 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, Mass., "until the devices and facilities have been shown to be in compliance" with the FDA's current good manufacturing practice (cGMP) requirements as set forth in the quality system regulation for devices, the agency said.

The devices affected 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.