LITHOCLAST FR-284Recalls & reported problems
E.M.S. Electro Medical Systems S.A. · Swiss LithoClast Trilogy Disposable Probe Ø3.9x440mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613353162603), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Compatibility Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2024Compatibility Problem
TRILOGY PROBE ATTACHED AND WORKED INITIALLY AND THEN FEW SECONDS INTO IT THE PROBE WAS NOT RECOGNIZED AS ATTACHED NOT ALLOWING MATCHING TO WORK. NEW PROBE HAD TO BE OPENED AND WORKED WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536589 ↗
Other Lithotriptor, Ultrasonic devices
- ShockPulse SPL-TGyrus ACMI, LLC · Lithotriptor, ultrasonic279 reports
- ShockPulse SPL-SGyrus ACMI, LLC · Lithotriptor, ultrasonic2 recalls159 reports
- SHOCKPULSE SPL-SRGyrus ACMI, LLC · Lithotriptor, Ultrasonic2 recalls97 reports
- ShockPulse SPL-GGyrus ACMI, LLC · Lithotriptor, ultrasonic2 recalls10 reports
- Lithotripsy Transducer ShockPulse-SE SPL-TCybersonics Inc · Lithotriptor, Ultrasonic1 recall24 reports
- ShockPulse SPL-FSGyrus ACMI, LLC · Lithotriptor, ultrasonic20 reports
- ShockPulse Lithotripsy Generator SPL-GCybersonics Inc · Lithotriptor, Ultrasonic8 reports
- Lithotripsy System ShockPulse-SE SPL-SCybersonics Inc · Lithotriptor, Ultrasonic7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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