FDA recall Z-2011-2023

Olympus Corporation of the Americas · Class I · device

Product

Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

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-2011-2023