FDA-Device2023-11-15Class I
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
Olympus Corporation of the Americas
Hazard
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
Sold states
US Nationwide distribution
Affected count
15942 devices
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0189-2024Don't want to check this manually?
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