FDA sends Philips warning letter for CT, nuclear imaging systems

Health Imaging News, April 28, 2008

The FDA issued a warning to Philips Medical Systems about problems with manufacturing procedures for its CT and nuclear imaging systems. The problems include failures to oversee proper device design and proper procedures to handle complaints. Inspections conducted at Philips' Cleveland facility, from July 24, 2007, through Sept. 27, 2007, and from Oct. 22, 2007, through Nov. 9, 2007, revealed that the devices were adulterated, said FDA officials. The agency noted that failure to promptly correct the violations may result in regulatory action being initiated by the FDA "without further notice," including seizure, injunction and/or civil money penalties.


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