Z-0193-2024 Class I Ongoing
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