Health product recall

Various Olympus Medical Endoscopes

Brand(s)
OLYMPUS MEDICAL SYSTEMS CORP.
Last updated

Summary

Product
Various Olympus Medical Endoscopes
Issue
Medical devices - Labelling and packaging
Medical devices - Sterility
What to do

Contact OLYMPUS: Tel: 1-888-387-4022 or by email at OCITECHSUPPORT@OLYMPUS.COM

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalog number

OES Cysto-Nephro Fiberscope

All lots.

CYF-5R
CYF-5

Visera Imaging System- Cysto-Nephro Videoscope

All lots.

CYF-V2
CYF-V2R

Rhino-Laryngofiberscope

All lots.

ENF-XP

Cysto-Nephro Videoscope

All lots.

CYF-VH

Evis Exera III Video System - Bronchovideoscope

All lots.

BF-XP190

Issue

As a result of catch up 510(k)s on the subject devices, the reprocessing instructions were changed. Specifically, the EtO gas mixture was revised to reflect the gas mixture that is commercially available and optionable reusable brushes were removed as a reprocessing accessory.

Recall Start Date: February 20, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Ear, nose and throat
Companies

Olympus Medical Systems Corp.

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

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-75223

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