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FDAOctober 12, 2023device

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

4953170402470

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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