Pentax Medical Company recalls Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and th…

Recall date

April 6, 2016

Source

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

Recall number

Z-2279-2016

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

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