medical Class I Updated 2023-11-15

Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF

Recalled Product

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model BF-1TH190 UDI-DI: 4953170335181; Model BF-H190 UDI-DI: 4953170335174; Model BF-Q170 UDI-DI: 4953170342912 Model BF-Q190 UDI-DI: 4953170335198
View official government recall

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