Z-0192-2024 Class I Ongoing

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

Recall Details

Product Type
Devices
Report Date
November 15, 2023
Initiation Date
October 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32211 devices

Product Description

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

Reason for Recall

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

Distribution Pattern

US Nationwide distribution

Code Information

Model BF-1TH190 UDI-DI: 4953170335181; Model BF-H190 UDI-DI: 4953170335174; Model BF-Q170 UDI-DI: 4953170342912 Model BF-Q190 UDI-DI: 4953170335198