FDA recall Z-2518-2018

Olympus Corporation of the Americas · Class II · device

Product

Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R

Reason for recall

Potential breakage of the endoscope s insertion tube bending section during surgical procedures

Distribution

US Nationwide and Canada

Key facts

Status
Terminated
Initiation date
2018-01-17
Report date
2018-08-01
Termination date
2019-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2518-2018