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

Olympus Corporation of the Americas: Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

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: 17,609 units Lot/code info: All serial numbers BF-P180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 UDI: 04953170339288 BF-Q180** EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 UDI: 04953170339301 BF-Q180-AC* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC UDI: 04953170340086 BF-1T180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 UDI: 04953170339325 BF-1TQ180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 UDI: 04953170339349

UPC codes

04953170339288, 04953170339301, 04953170340086, 04953170339325, 04953170339349

Source

Official record: FDA (Device enforcement)

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

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