FDA DeviceClass IINotable

FDA Recall: Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System -

Name: FDA Recall: Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System -
Brand: Olympus Corporation of the Americas

Date: 2026-03-11

Brand: Olympus Corporation of the Americas

Category: Medical Device

FDA Class: Class II

Description

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.