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PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE
UNITED MEDICAL SYSTEMS (DE), INC. · Model P3000002 · UDI-DI 00811779030002
10
510(k) clearances
815
Adverse events (30 deaths)
1
Recalls
18
Facilities
Description
Extracorporeal Shockwave Lithotripsy (ESWL) System for non-invasive disintegration of calculi located in the kidneys and urinary tract. Comprised of ESWL control unit, Litho arm for Philips BV Pulsera c-arm, Philips BV Pulsera x-ray, Sonoace X6 Ultrasound, Oakworks CFLU401 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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