Olympus Corporation of the Americas: Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockP

Hazard

Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Details from the source

Reason for recall: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. Quantity: 1684 units Lot/code info: Model/Catalog Number: SPL-G; UDI: 00821925044203; Serial Numbers: All;

UPC codes

00821925044203

Source

Official record: FDA (Device enforcement) ↗

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