FDA-Device2021-10-06Class II
BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
Olympus Corporation of the Americas
Hazard
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Sold states
Domestic distribution nationwide. Product also distributed globally.
Affected count
1177
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2571-2021Don't want to check this manually?
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