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FDA DeviceClass IINotable

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

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.

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.

Remedy

602 units

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