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PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE
UNITED SERVICE SOLUTIONS, LLC · Model P3000002 · UDI-DI 00810000980482
1
510(k) clearances
811
Adverse events (30 deaths)
1
Recalls
18
Facilities
Description
Extracorporeal Shockwave Lithotripsy System (ESWL) - ESWL Control Unit, Litho Arm for X-ray C-arm, X-ray C-arm, Ultrasound Device, Lithotripsy Table
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-09-24 | Siemens Medical Solutions USA, Inc | Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
