Z-0193-2024 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
719 devices

Product Description

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

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-XT190 UDI-DI: 4953170402470