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Pentax Medical Company recalls Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy i
Recalled July 6, 2016 · FDA recall Z-2067-2016 · Pentax Medical
Hazard
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. · FDA Class II
Units
50 units
Sold at
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Description
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Product
Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Manufacturer(s)
Pentax Medical Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →