Olympus America Inc. recalls EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus vid…

Recall date

March 26, 2015

Source

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

Recall number

Z-2807-2015

FDA classification

Class II

Brand / firm

Olympus America Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.

Why it was recalled

New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.

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 Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.