FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order
US FDA sent the letters to
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The US FDA continues to find unacceptable levels of “high concern” disease-causing bacteria on duodenoscopes that have gone through cleaning and reprocessing steps, and is poised to take further action with three duodenoscope manufacturing firms to reduce patient risks.
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An early look at the results of post-market studies that had been ordered by US FDA for duodenoscopes highlights ongoing sterilization issues.
Warning Letter Roundup & Recap – March 13, 2018
Duodenoscope-makers Olympus, Fujifilm and Pentax Medical failed to conduct post-market surveillance study activities mandated by US FDA in 2015; quality systems violations noted at firms that make dental diagnostic X-ray devices and laser fiber-optic surgical devices. Six device-related warning letters were released by the agency this week.