Recall Z-2520-2018— Olympus Corporation of the Americas

Name: FDA recall Z-2520-2018
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: K172298. Product: Uretero-reno fiberscope URF-P6RP6. Reason: 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

K172298 — OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.·cleared 2018-03-29

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 fiberscope URF-P6RP6

Reason for recall

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.