—#181234

Product

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

FDA product code: FEO — Lithotriptor, Ultrasonic
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K142428
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

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

Timeline

Recall initiated: 2020-04-23
Terminated: 2024-10-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181234. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.