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General Electric's OEC Medical Systems signs consent decree.

Publication: FDA Consumer
Publication Date: 01-MAR-07 		Format: Online
Delivery: Immediate Online Access
Full Article Title: General Electric's OEC Medical Systems signs consent decree.(prohibiting the manufacture of X-ray surgical imaging systems)

Article Excerpt
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....

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