Pentax Medical Company recalls Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. Th

Recalled July 6, 2016 · FDA recall Z-2071-2016 · 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

9,669 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

Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth 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 →