FDA recall Z-3290-2018

Olympus Corporation of the Americas · Class II · device

Product

Bronchovideoscope BF-3C160

Reason for recall

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Distribution

The products were distributed US nationwide and Canada.

Key facts

Status: Terminated
Initiation date: 2018-08-08
Report date: 2018-10-10
Termination date: 2022-05-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3290-2018