Home › Device types › FEO
Lithotriptor, Ultrasonic
FDA product code FEO · Class 2 · Gastroenterology, Urology
98
Registered devices
1,213
Adverse events
7
Recalls
14
510(k) clearances
Devices with this code
SHOCKPULSE — Gyrus ACMI, LLCLITHOCLAST — E.M.S. Electro Medical Systems S.A.SHOCKPULSE — Gyrus ACMI, LLCn.a. — Karl Storz GmbH & Co. KGShockPulse — Gyrus ACMI, LLCOlympus — Gyrus ACMI, LLCPROBE FOR LUS-2 2.0mm O.D — OLYMPUS MEDICAL SYSTEMS CORP.SHOCKPULSE — Gyrus ACMI, LLCGyrus ACMI — Gyrus ACMI, LLCLITHOCLAST — E.M.S. Electro Medical Systems S.A.Probe uncologging rod — OLYMPUS MEDICAL SYSTEMS CORP.Foot Swtich for LUS-2 — OLYMPUS MEDICAL SYSTEMS CORP.LITHOCLAST — E.M.S. Electro Medical Systems S.A.LITHOCLAST — E.M.S. Electro Medical Systems S.A.n.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGLithotripsy Probe, Sterile Single Use ShockPulse -SE, 2.9 Fr (0.97mm) X 578mm — CYBERSONICS INCn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGDebris Collection Bottle for LUS/LUS-2 — OLYMPUS MEDICAL SYSTEMS CORP.n.a. — Karl Storz GmbH & Co. KGShockPulse — Gyrus ACMI, LLCCALCUSON — Karl Storz GmbH & Co. KG
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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