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FDA (Device enforcement)Recalled 2023-06-08class i

Olympus Corporation of the Americas: Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

Hazard

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Details from the source

Reason for recall: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. Distribution: US Nationwide Distribution. Quantity: 9,684 units Lot/code info: All serial numbers BF-H190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 UDI: 04953170434754 BF-Q190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 UDI: 04953170335198 BF-XT190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190UDI: 04953170402470 BF-1TH190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 UDI: 04953170434778

UPC codes

04953170434754, 04953170335198, 04953170402470, 04953170434778

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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