Health product recall

Evis Exera III Duodenovideoscope

Last updated

Summary

Product
Evis Exera III Duodenovideoscope
Issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Evis Exera III Duodenovideoscope All lots. TJF-Q190V

Issue

Olympus is initiating this action after becoming aware of recent reports of infections and positive cultures and inquiries from the FDA regarding these reports. Olympus is reminding users to closely follow reprocessing instructions, including periodic inspections by Olympus service, and informing users about an updated manual intended to improve comprehension of existing steps. Olympus is reminding users that the use of a damaged or contaminated endoscope can present an infection risk to patients.

Recall start date: le 22 septembre, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies

Olympus Medical Systems Corp.

2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74400