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Olympus Corporation of the Americas recalls EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Recalled November 15, 2023 · FDA recall Z-0193-2024 · 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. · FDA Class I
Units
719 devices
Sold at
US Nationwide distribution
Description
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.
Product
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →