Home › Device types › FEO
Lithotriptor, Ultrasonic
FDA product code FEO · Class 2 · Gastroenterology, Urology
98
Registered devices
1,264
Adverse events
7
Recalls
14
510(k) clearances
Devices with this code
n.a. — Karl Storz GmbH & Co. KGUS-LITHO — Richard Wolf GmbHn.a. — Karl Storz GmbH & Co. KGLITHOCLAST — E.M.S. Electro Medical Systems S.A.n.a. — Karl Storz GmbH & Co. KGLITHOCLAST — E.M.S. Electro Medical Systems S.A.n.a. — Karl Storz GmbH & Co. KGSHOCKPULSE — Gyrus ACMI, LLCn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGLITHOCLAST — E.M.S. Electro Medical Systems S.A.LITHOCLAST — E.M.S. Electro Medical Systems S.A.Drain Tube for LUS-2 — OLYMPUS MEDICAL SYSTEMS CORP.Foot Swtich for LUS-2 — OLYMPUS MEDICAL SYSTEMS CORP.ShockPulse — Gyrus ACMI, LLCLITHOCLAST — E.M.S. Electro Medical Systems S.A.n.a. — Karl Storz GmbH & Co. KGSHOCKPULSE — Gyrus ACMI, LLCSHOCKPULSE — Gyrus ACMI, LLCProbe for LUS-2 2.0mm O.D. — OLYMPUS MEDICAL SYSTEMS CORP.LITHOCLAST — E.M.S. Electro Medical Systems S.A.SHOCKPULSE — Gyrus ACMI, LLCOlympus — Gyrus ACMI, LLCLITHOCLAST — E.M.S. Electro Medical Systems S.A.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-08 | Olympus Corporation of the Americas | 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 consi |
| 2025-11-14 | Olympus Corporation of the Americas | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the |
| 2025-11-14 | Olympus Corporation of the Americas | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the |
| 2025-11-14 | Olympus Corporation of the Americas | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the |
| 2025-10-08 | Olympus Corporation of the Americas | 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 |
| 2022-07-07 | Olympus Corporation of the Americas | 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 consi |
| 2020-04-23 | Olympus Corporation of the Americas | A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization. |
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