FDA recall Z-0193-2024

Olympus Corporation of the Americas · Class I · device

Product

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

Reason for recall

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.

Distribution

US Nationwide distribution

Key facts

Status: Ongoing
Initiation date: 2023-10-12
Report date: 2023-11-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0193-2024