Pentax Medical Company recalls Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access…

Recall date

April 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2077-2016

FDA classification

Class II

Brand / firm

Pentax Medical Company

Sold / distributed

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric