FDA-Device2021-09-29Class II
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Olympus Corporation of the Americas
Hazard
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
Sold states
US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.
Affected count
27 globally (21 US)
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2497-2021Don't want to check this manually?
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