Z-2014-2023 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
284 units

Product Description

Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

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-XT160* EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 UDI: 04953170340147