PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE P3000002Recalls & reported problems
United Service Solutions, LLC · Extracorporeal Shockwave Lithotripsy System (ESWL) - ESWL Control Unit, Litho Arm for X-ray C-arm, X-ray C-arm, Ultrasound Device, Lithotripsy Table · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810000980567), received between Feb 21, 2025 and Feb 21, 2025 — classified as 1 death.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2025, WE WERE NOTIFIED THAT THE PATIENT PASSED AWAY AFTER HAVING AN EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY TREATMENT USING THE PIEZOLITH 3000 TRIPLE FOCUS MACHINE. THE PATIENT WAS TREATED ON (B)(6) 2024 AND PASSED AWAY ON (B)(6) 2024. AN INVESTIGATION INTO THIS EVENT IS UNDERWAY. IT IS UNCLEAR WHETHER THE EVENT IS RELATED TO THE DEVICE. A SUPPLEMENTAL MDR WILL BE SUBMITTED AS NEEDED AS THE INVESTIGATION EVOLVES.
Patient problems: Insufficient Information
MAUDE report 21437755 ↗
Other Lithotriptor, Extracorporeal Shock-Wave, Urological devices
- Dornier MedTech Delta IIIDornier MedTech GmbH · Lithotriptor, Extracorporeal Shock-Wave,Urological26 reports
- MODULITH® SLX-F2Storz Medical AG · Lithotriptor, Extracorporeal Shock-Wave,Urological17 reports
- Dornier MedTech Compact SigmaDornier MedTech GmbH · Lithotriptor, Extracorporeal Shock-Wave,Urological17 reports
- MODULITH® SLX-F2Storz Medical AG · Lithotriptor, Extracorporeal Shock-Wave,Urological2 deaths15 reports
- Modularis Variostar 01157200Siemens Healthcare GmbH · Lithotriptor, extracorporeal shock-wave,urological1 report
- Dornier Delta III K1045938Dornier MedTech GmbH · Lithotriptor, Extracorporeal Shock-Wave, Urological1 report
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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