Estimated read time: Less than a minute
This archived news story is available only for your personal, non-commercial use. Information in the story may be outdated or superseded by additional information. Reading or replaying the story in its archived form does not constitute a republication of the story.
SALT LAKE CITY (AP) -- A Salt Lake City medical manufacturer has been shut down after the US Food and Drug Administration found its surgical imaging devices could put patients at risk.
The FDA announced a consent decree with GE OEC Medical Systems yesterday. An audit last fall found violations of federal quality assurance regulations.
The company, a subsidiary of General Electric, stopped shipping its fluoroscopic X-ray and navigation systems following the audit.
The devices are commonly used by doctors to see inside the body during minimally invasive surgeries.
Under the decree, the company can't manufacture or sell equipment until it complies with federal law.
About 30 Utah employees have been put on furlough. A G-E Healthcare plant in Lawrence, Massachusetts is also affected.
Information from: The Deseret Morning News
(Copyright 2007 by The Associated Press. All Rights Reserved.)
