inforMED
MalfunctionFEO

SHOCKPULSE-SE LITHOTRIPSY SYSTEM

Received Jul 20, 2026 · Event occurred Jun 26, 2026

Report 3011050570-2026-00745 · MDR key 25874891

Device

Generic name

Lithotriptor, Ultrasonic

Manufacturer

Gyrus Acmi, Inc.

Model number

SPL-S

Product problems

  • Failure to Power Up
  • Activation Failure

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions