United StatesThe recall affects the ShockPulse Lithotripsy Transducer (Brand: Lithotriptor; Product: ShockPulse; Model/Catalog SPL-T; UDI-PI 00855279005023; all serial numbers), a reusable transducer for the ShockPulse Lithotripsy System. It was recalled because the device may fail to start or may start briefly then stop with an error light on the generator, and the transducer handpiece body may gradually increase in temperature during clinical use. The units were distributed worldwide (including the US, Canada, India, Taiwan, Germany, Australia, and Singapore); 1,528 units were involved.
What's being recalled
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones. Component: ShockPulse Lithotripsy System
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;
The hazard
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)