FDA recall Z-1116-2022

Olympus Corporation of the Americas · Class II · device

Product

Olympus Uretero-reno videoscope, Model No. URF-V2

Reason for recall

The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.

Distribution

US Nationwide distribution in the state of AZ.

Key facts

Status
Ongoing
Initiation date
2022-03-25
Report date
2022-05-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1116-2022