Lithotriptor, Ultrasonic
Gastroenterology, Urology · 21 CFR 876.4480
Recent MDR events
1,213 adverse event reports on file
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 27, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00758
- SHOCKPULSE LITHOTRIPSY FOOTSWITCHJul 27, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00759
- SHOCKPULSE LITHOTRIPSY TRANSDUCER.Jul 27, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00764
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 27, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00765
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 21, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00753
- SHOCKPULSE LITHOTRIPSY TRANSDUCER.Jul 21, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00756
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 20, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00745
- SHOCKPULSE LITHOTRIPSY TRANSDUCER.Jul 20, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00749
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 20, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00750
- SHOCKPULSE LITHOTRIPSY FOOTSWITCHJul 20, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00752
Event type breakdown
Recalls
7 recall events for this product code
- Olympus Corporation of the AmericasOpen, ClassifiedMar 5, 2026
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
Z-1494-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 27, 2026
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR
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.
Z-1477-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 27, 2026
Brand Name: ShockPulse-SE Lithotripsy System SPL-S
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.
Z-1478-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 27, 2026
Brand Name: ShockPulse-SE Lithotripsy System
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.
Z-1479-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedNov 7, 2025
Brand Name: Lithotriptor, Ultrasonic
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
Z-0452-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedUnknown
ShockPulse-SE Lithotripsy Generator
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment
Z-1514-2022 · View FDA record ↗ - Olympus Corporation of the AmericasTerminatedUnknown
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Z-2197-2020 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
E.m.s. Electro Medical Systems S.a.
NYON Vaud, CH
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
E.m.s. Electro Medical Systems S.a.
NYON Vaud, CH
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Isomedix Operations Inc.
Northborough, MA, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Lynx Medical Nj
Franklin, NJ, US
Primo Medical Group, Inc
W Bridgewater, MA, US
Electro Medical Systems, L.l.c.
Southlake, TX, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Nissha Medical Technologies (ohio), Inc.
Norwalk, OH, US
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Promepla S.a.m
MONACO Monaco-Ville, MC
510(k) clearances
14 clearances for this product code
- E.M.S Electro Medical Systems S.AOct 23, 2023
K230893 · Swiss LthoClast Trilogy
- E.M.S Electro Medical Systems S.AOct 9, 2018
K182490 · Swiss LithoClast Trilogy
- E.M.S Electro Medical Systems S.AAug 30, 2018
K181997 · Swiss LithoClast Trilogy
- E.M.S Electro Medical Systems S.AJun 20, 2018
K181364 · Swiss LithoClast Trilogy
- E.M.S Electro Medical Systems S.AJan 10, 2018
K173234 · Swiss LithoClast Trilogy
- Cybersonics, Inc.Aug 21, 2017
K171024 · ShockPulse-SE Lithotripsy System
- Cybersonics, Inc.Nov 13, 2014
K142428 · Shock Pulse-SE Lithotripsy System CYBERWAND II
- Fibra Sonics, Inc.Nov 22, 1999
K993046 · FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000