Dornier Delta III K1045938Recalls & reported problems
Dornier MedTech GmbH · Dornier Delta III Pro - DELTA III PRO XRAY 15KW/SW E180 DMT-A · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049957006471), received between Aug 8, 2023 and Aug 8, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA AND COMPLICATION WAS REPORTED TO HAVE OCCURED IN TWO PATIENTS, AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00025 ON 07/26/2023.
Patient problems: Hematoma
MAUDE report 17477741 ↗
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
- PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE P3000002United Service Solutions, LLC · Lithotriptor, Extracorporeal Shock-Wave, Urological1 death1 report
- Modularis Variostar 01157200Siemens Healthcare 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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