Z-2012-2023 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
4 units

Product Description

Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

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-PE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 UDI: 04953170339974 BF-TE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 UDI: 04953170339998