Olympus Corporation of the Americas recalls EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documenta…

Recall date

March 15, 2016

Source

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

Recall number

Z-1845-2016

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

Nationwide:

Why it was recalled

New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.

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 Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.