Z-2014-2023 Class I Ongoing
FDA device recall Z-2014-2023 was initiated by Olympus Corporation of the Americas on June 8, 2023 and is designated Class I. Reason for recall: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. The recall status is ongoing. Affected quantity: 284 units.
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
- 284 units
Product Description
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
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-XT160* EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 UDI: 04953170340147