The FDA updated its safety alert concerning the Pentax ED-3490TK duodenoscope after Pentax identified a new risk with the ED-3490K duodenoscope. Here’s what you should know. 1. Pentax identified ...

More than 20 million gastrointestinal endoscopic procedures are performed each year in the United States. According to the American Society for Gastrointestinal Endoscopy (ASGE), the risk of infection ...

The FDA sent warning letters to three duodenoscope manufacturers — Olympus Corp., Fujifilm and Pentax — March 9 for failing to conduct mandatory postmarket surveillance studies into the efficacy of ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. Back to Healio The FDA has issued an update to its ...

The US Food and Drug Administration (FDA) has issued an updated safety communication on the ED-3490TK video duodenoscope from Pentax regarding a design problem that could increase the risk for patient ...

MONTVALE, N.J., Feb. 19, 2016 /PRNewswire/ -- PENTAX Medical has announced that the company updated the Reprocessing and Operation Instructions for Use ("IFU") for the PENTAX Medical ED-3490TK Video ...

Please provide your email address to receive an email when new articles are posted on . The FDA has issued an update to its safety communication regarding the risk for infection associated with the ...

The Food and Drug Administration on Wednesday approved Pentax of America's new duodenoscope, which features a disposable distal cap to improve device cleaning and reprocessing. Duodenoscopes are ...

Device Features Sterile, Disposable Cap and Elevator to Reduce Contamination and Minimize Reprocessing Burdens MONTVALE, N.J.--(BUSINESS WIRE)--PENTAX Medical, a healthcare industry leader in ...

Pentax Medical is voluntarily recalling all ED-3490TK video duodenoscopes in order to replace the forceps elevator mechanism, O-rings, and the distal end covering and to update the operation manual to ...