Pentax Medical Company recalls Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointes…

Recall date

April 6, 2016

Source

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

Recall number

Z-2276-2016

FDA classification

Class II

Brand / firm

Pentax Medical Company

Sold / distributed

US Nationwide Distribution

Why it was recalled

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

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