inforMED
MalfunctionFEO

SHOCKPULSE LITHOTRIPSY TRANSDUCER.

Received Jul 27, 2026 · Event occurred Jul 1, 2026

Report 3011050570-2026-00764 · MDR key 50038876

Device

Generic name

Lithotriptor, Ultrasonic

Manufacturer

Gyrus Acmi, Inc.

Model number

SPL-T

Product problems

  • Gas/Air Leak

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions