Z-0686-2024 Class II Ongoing

Recalled by Shirakawa Olympus Co., Ltd. — Nishishirakawa-Gun

Recall Details

Product Type
Devices
Report Date
January 17, 2024
Initiation Date
December 4, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2600 US; 3214 OUS

Product Description

Model No. BF-P190, EVIS EXERA III Bronchovideoscope

Reason for Recall

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

Distribution Pattern

US Nationwide distribution.

Code Information

UDI-DI: 04953170342110 All serial numbers