FDA-Device2018-10-10Class II

Bronchovideoscope BF-160

Olympus Corporation of the Americas
Hazard

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Sold states
The products were distributed US nationwide and Canada.
Affected count
3948
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Bronchovideoscope BF-160

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3283-2018

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