WEDNESDAY, Jan. 17 (HealthDay News) -- GE Healthcare and its subsidiary GE OEC Medical Systems signed a consent decree of permanent injunction on Jan. 12 prohibiting the manufacture and distribution of certain X-ray surgical imaging systems due to manufacturing deficiencies, according to the U.S. Food and Drug Administration.
The imaging systems include the 9900 Elite C-Arm System, the 9900 Elite NAV C-Arm System, the 9800 C-Arm System, the 2800 UroView System, the 6800 MiniView System, the Insta-Trak 3500 NAV System, and the ENTrak 2500 NAV System, as well as their components and accessories. The systems are manufactured in Salt Lake City, Utah, and Lawrence, Mass.
The FDA inspected GE OEC Medical Systems Utah facility in 2004 and issued a Warning Letter in 2005 after finding violations of current good manufacturing practice (CGMP) requirements. The deficiencies persisted during FDA's inspection of the same facility in 2006, leading to the signing of the decree.
Under the terms of the decree, the company agreed to take corrective measures to ensure that the facilities comply with CGMP requirements and have an independent expert conduct inspections of the two facilities.
GE OEC Medical Systems has also initiated a recall on several models of its X-ray surgical imaging systems.
More Information -- FDA
More Information -- GE Healthcare
