Z-2197-2020Class II

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

Name: Z-2197-2020 OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Creator: Olympus Corporation of the Americas
Published: 2020-04-23
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2020-04-23 / Terminated / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer on 2020-04-23. FDA classified it as Class II and gives the reason as "A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2197-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-23
Posted: 2020-06-01
Terminated: 2024-10-09
Recalling firm: OLYMPUS Corporation of the Americas
Product: OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Product code: FEO Lithotriptor, Ultrasonic
Reason for recall: A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Root cause tag: design
FDA root cause: Component design/selection
Action: Olympus sent a Medical Device Field Removal Action letter, dated April 23, 2020, to all ShockPulse Transducer (Model SPL-T) customers with the affected serial numbers. The letter states that the transducer was manufactured with non-conforming material and could become warped during sterilization. They explained that the serial number of the transducers is found etched on the back of the device. The firm asked that the customers determine whether they have any of the affected product in stock. If customers have any of the affected product , they were instructed to quarantine the product. and contact the Olympus customer service representative at 1-888-524-7266 option 1, in order to receive a Return Material Authorization for any affected product then, get issued a credit or replacement. Customers were also instructed to access the Olympus recall portal (https://olympusamerica.com/recall) to indicate that they received the notification. If they distributed the product further, the firm asked them to notify their customers to inform them of the field action.
Quantity in commerce: 18
Distribution: Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2197-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2197-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-01

Product code FEO

K142428Class IIShock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc. / cleared 2014-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)