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Sonolith Electrode
EDAP-TMS FRANCE · Model TMS 220830 · UDI-DI 03661690000045
MMZ
Prescription
1
510(k) clearances
26
Adverse events
5
Recalls
16
Facilities
Description
The SONOLITH® electrode is the consumable/ disposable component for the SONOLITH® 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 |
|---|---|---|
| 2017-03-08 | Sonesta Medical Ab | The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight. |
| 2009-11-03 | Stille AB | There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during |
| 2009-11-03 | Stille AB | There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during |
| 2009-11-03 | Stille AB | There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during |
| 2006-10-01 | Siemens Medical Solutions USA, Inc | Potential pinch point with the patient table |
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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.