FDA recall Z-2490-2023

Olympus Corporation of the Americas · Class II · device

Product

Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.

Reason for recall

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-07-27
Report date
2023-09-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2490-2023