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Latest From Pentax Medical
Custom Ultrasonics' System 83 Plus automated endoscope reprocessors may now be used to disinfect specific models of Olympus and Pentax duodenoscopes, FDA says.
FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order
US FDA sent the letters toOlympus Corp., Fujifilm Medical Systems USA Inc. and Pentax Medical after the firms failed to meet obligations to conduct Sec. 522 post-market studies on their duodenoscopes, the use of which caused a number of antibiotic-resistant superbug infections in 2013 and 2014.
US FDA, CDC and medical groups joined forces to develop safer handling standards for the endoscope equipment, which has been tied to infection outbreaks.
The device from Pentax features a disposable distal cap, thus cutting the risk of infection transmission between patients. An earlier Pentax duodenoscope model was the subject of an infection-related safety alert in January.
- Diagnostic Imaging Equipment & Supplies
- Therapeutic Areas
- Gynecological, Urological
- Respiratory, Pulmonary
- Asahi Optical Co.
- Pentax Medical Co.
- Pentax Precision Instrument Corp.
- North America
- Parent & Subsidiaries
- Hoya Corp.
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Gene Merante, VP, Fin.
Victor Capo, VP, Operations
Joe Dawson, VP, Sales & Mktg.
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