Recall Z-2197-2020— Olympus Corporation of the Americas

Name: FDA recall Z-2197-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-23

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2020-04-23, terminated 2024-10-09. It names one FDA 510(k) clearance: K142428. Product: OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer. Reason: A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2020-04-23
Terminated: 2024-10-09
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K142428 — Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc.·cleared 2014-11-13

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

OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer

Reason for recall

A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.

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