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Carbon Fiber Table W2E
EDAP-TMS FRANCE · Model TMS 234181 · UDI-DI 03661690000151
1
510(k) clearances
26
Adverse events
5
Recalls
16
Facilities
Description
A carbon fiber table with removable right and left panels for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy).
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.