FDA-Device2023-11-15Class I
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
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
719 devices
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0193-2024Don't want to check this manually?
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