Olympus Corporation of the Americas: Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy Sy

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore. Quantity: 1528 units Lot/code info: Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;

UPC codes

00855279005023

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.