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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus

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 Class 2 Device Recall Olympussee related information
Date Initiated by FirmApril 23, 2020
Create DateJune 01, 2020
Recall Status1 Terminated 3 on October 09, 2024
Recall NumberZ-2197-2020
Recall Event ID 85558
510(K)NumberK142428 
Product Classification Lithotriptor, ultrasonic - Product Code FEO
ProductOLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
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
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information ContactMs. Laura Storms
484-896-5688
Manufacturer Reason
for Recall		A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
FDA Determined
Cause 2		Component design/selection
ActionOlympus 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 Commerce18
DistributionDistribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FEO
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