Recall Z-1845-2016— Olympus Corporation of the Americas

Name: FDA recall Z-1845-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-15

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2016-03-15, terminated 2018-02-06. It names one FDA 510(k) clearance: K024033. Product: 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.. Reason: 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Terminated: 2018-02-06
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K024033 — XTJF-160AF DUODENOVIDEOSCOPEOlympus Optical Co., Ltd.·cleared 2002-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.