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Sonolith i-move Visio-Track Module
EDAP-TMS FRANCE · Model TMS 239271 · UDI-DI 03661690000113
1
510(k) clearances
811
Adverse events (30 deaths)
1
Recalls
18
Facilities
Description
SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency.
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.