Home › EDAP-TMS FRANCE › Sonolith Carbon Fiber Table
Sonolith Carbon Fiber Table
EDAP-TMS FRANCE · Model TMS 230811 · UDI-DI 03661690000083
4
510(k) clearances
26
Adverse events
5
Recalls
16
Facilities
Description
One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lithotnpsy).
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.