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Olympus America Inc. recalls EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus
Recalled September 30, 2015 · FDA recall Z-2807-2015 · Olympus America
Hazard
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. · FDA Class II
Units
6109
Sold at
Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
Description
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.
Product
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.
Manufacturer(s)
Olympus America Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →