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Model No. BF-P190, EVIS EXERA III Bronchovideoscope

FDA Recall #Z-0686-2024 — Class II — December 4, 2023

Recall #Z-0686-2024 Date: December 4, 2023 Classification: Class II Status: Ongoing

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.

Recalling Firm

Shirakawa Olympus Co., Ltd. — Nishishirakawa-Gun

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2600 US; 3214 OUS

Distribution

US Nationwide distribution.

Code Information

UDI-DI: 04953170342110 All serial numbers

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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