Olympus Corporation of the Americas recalls EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound…

Recall date

August 21, 2015

Source

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

Recall number

Z-2818-2015

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

Nationwide Distribution

Why it was recalled

Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope

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

What was recalled

EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.