PlainRecalls
FDA Devices Moderate Class II Ongoing

Model No. BF-P190, EVIS EXERA III Bronchovideoscope

Reported: January 17, 2024 Initiated: December 4, 2023 #Z-0686-2024

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.

Details

Units Affected
2600 US; 3214 OUS
Distribution
US Nationwide distribution.
Location
Nishishirakawa-Gun

Frequently Asked Questions

What product was recalled?
Model No. BF-P190, EVIS EXERA III Bronchovideoscope. Recalled by Shirakawa Olympus Co., Ltd.. Units affected: 2600 US; 3214 OUS.
Why was this product recalled?
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0686-2024.