FDA Enforcement
Class I
Ongoing
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Recall: Z-0193-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0193-2024
- Event ID
- 93052
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- October 12, 2023
- Classification Date
- November 9, 2023
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Reason
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.
Code Info
Model BF-XT190 UDI-DI: 4953170402470
Distribution
US Nationwide distribution
Quantity
719 devices