Various Olympus Medical Endoscopes
Brand(s)
Summary
Contact OLYMPUS: Tel: 1-888-387-4022 or by email at OCITECHSUPPORT@OLYMPUS.COM
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
OES Cysto-Nephro Fiberscope |
All lots. |
CYF-5R |
Visera Imaging System- Cysto-Nephro Videoscope |
All lots. |
CYF-V2 |
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
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
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