Pentax Medical Company recalls Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. Thi…

Recall date

April 6, 2016

Source

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

Recall number

Z-2069-2016

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

Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.