Model note · Lithotripter (ESWL)
Dornier Delta III lithotripter
The Dornier Delta III is a modular urology workstation for extracorporeal shock wave lithotripsy (ESWL) of kidney and upper ureteral stones, also used for other imaging guided urological procedures. It combines an electromagnetic shock wave emitter (EMSE) on a therapy arm, an integrated X-ray C-arm and an optional ultrasound arm with a motorised urology table. A camera in the therapy head lets staff see air inclusions in the coupling interface between the treatment head and the patient.
The model
Maker, model and type.
- Maker
- Dornier MedTech (Dornier MedTech America, Inc.)
- Model
- Delta III lithotripter
- Device type
- Lithotripter (ESWL)
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Indication | Fragmentation of renal calyceal, renal pelvic and upper ureteral stones | Source |
| Modules | Three modules: a basic unit carrying both the X-ray C-arm and the camera equipped therapy arm, a urology patient table, and a control desk with image storage (UIMS) | Source |
| Shock wave source | Electromagnetic shock wave emitter (EMSE); EMSE 180 on current units | Source |
| Penetration depth | 170 mm (EMSE 180) | Source |
| X-ray generator | 15 kW, up from 3.5 kW on the Compact Delta predicate | Source |
| Imaging | X-ray, ultrasound or both; optional SonoScape X3 Pro ultrasound added in the 2020 clearance; DICOM 3 PACS connection | Source |
| Therapy head access | Over table and under table positions, more than 120 degrees of access | Source |
| Standards | IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-36 (lithotripsy), 60601-2-28, 60601-2-54, IEC 62366-1 | Source |
| FDA clearances | K170122 (2017), K172084 (2017), K201074 (2020); Delta III Pro K221903 (2023); product code LNS | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Haematoma is the dominant reported patient problem (167 MAUDE reports) and Dornier lists it as a potential complication in the operating manual; in the reports sampled, field service usually found the device within specification. Source
- In one reported haematoma case, service found the F2 focus 2 mm outside Dornier's specified position and realigned it, which shows why the daily alignment check matters. Source
- The system includes a diagnostic X-ray unit and must be operated under X-ray radiation protection rules (IEC 60601-1-3). Source
Sources
Where this note comes from.
- Dornier Delta III product page (Americas)
- FDA 510(k) K201074 summary, Delta III Lithotripter
- FDA 510(k) K170122 summary, Delta III Lithotripter
- openFDA MAUDE problem counts, Delta III
- openFDA MAUDE patient problem counts, Delta III
- openFDA MAUDE device problem reports, Delta III
- openFDA 510(k) search, Delta III
Not covered: The Delta III operating and service manuals are not public, so there are no error codes, energy levels, focal zone dimensions or shock rate limits; acoustic output data was not in the 510(k) summaries reviewed. No FDA recalls were found for the Delta III (the only Dornier recall found concerned laser fibres). The EMSE 180 and 170 mm figures come from Dornier's current page and may apply only to newer units.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
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