Z-2016-2023 Class I Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
July 26, 2023
Initiation Date
June 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17,609 units

Product Description

Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

Reason for Recall

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

Distribution Pattern

US Nationwide Distribution.

Code Information

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