FDA-Device2022-05-18Class II
BF-1TQ180: EVIS EXERA II Bronchovideoscope
Olympus Corporation of the Americas
Hazard
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Sold states
US Nationwide distribution.
Affected count
242 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
BF-1TQ180: EVIS EXERA II Bronchovideoscope
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1049-2022Don't want to check this manually?
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