Recall Z-2518-2018— Olympus Corporation of the Americas

Name: FDA recall Z-2518-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-17

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2018-01-17, terminated 2019-12-04. It names one FDA 510(k) clearance: K172246. Product: Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R. Reason: Potential breakage of the endoscope s insertion tube bending section during surgical procedures.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2018-01-17
Terminated: 2019-12-04
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K172246 — OLYMPUS URF-V2/V2ROlympus Medical Systems Corp.·cleared 2018-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.