FDA-Device2024-01-17Class II
Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Shirakawa Olympus Co., Ltd.
Hazard
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Sold states
US Nationwide distribution.
Affected count
2600 US; 3214 OUS
Manufactured in
Azaokamiyama 3-1, Oazaodakura; Nishigo-Mura, Nishishirakawa-Gun, Japan
Products
Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0686-2024Don't want to check this manually?
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