FDA-Device2021-10-06Class II
BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
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
293
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2570-2021Don't want to check this manually?
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