There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
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
04953170434754, 04953170335198, 04953170402470, 04953170434778
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.