Home / Recalls / Olympus Corporation of the Americas / Z-2197-2020

Z-2197-2020 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
June 10, 2020
Initiation Date
April 23, 2020
Termination Date
October 9, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18

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.

Distribution Pattern

Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.

Code Information

Serial numbers: 1910PW30607705, 1910PW30607712, 1910PW30607601, 1910PW30607708, 1910PW30607709, 1910PW30607701, 1910PW30607814, 1910PW30607906, 1910PW30607603, 1910PW30607706, 1910PW30607802, 1910PW30607808, 1910PW30607809, 1910PW30607804, 1910PW30607713, 1910PW30607803 Lot Numbers: CG2003, CG2010, CG2011, CG2026, CG2027, CG2033, CG2035, CG2000, CG2025, CG2001, CG2019, CG2022, CG2029, CG2021, CG2008, CG2036, CG2037, CG2006, CG2004, CG2007, CG2012, CG2013, CG2015

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