Z-2011-2023 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
1535 units

Product Description

Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

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-XT40** OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 UDI: 04953170055980 BF-P60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 UDI: 04953170339288 BF-MP60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 UDI: 04953170338394 BF-1T60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 UDI: 04953170339264