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

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

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.