FDA recall Z-2013-2023
Olympus Corporation of the Americas · Class I · device
Product
Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
Reason for recall
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Distribution
US Nationwide Distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-06-08
- Report date
- 2023-07-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Center Valley, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2013-2023