Olympus Corporation of the Americas recalls Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used wi…

Recall date

January 8, 2016

Source

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

Recall number

Z-0757-2016

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

US Nationwide Distribution except PR

Why it was recalled

Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.

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

What was recalled

Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.