FDAClass IISeptember 30, 2015

EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. recall

EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source…

Why was EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: TJF-Q180V, all sold units

Product
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source…
Recalling firm
Olympus America Inc.
Quantity
6109
Distribution
Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
Recall date
September 30, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls