Facility
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3004096429 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | RTE DE CHAMP-COLIN 2 NYON Vaud, CH 1260 |
| Registration status | Active · expires 2026 |
| Parent company | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. (owner-operator 9057430) |
| Brand names | DolorClast Radial |
Devices registered here (1)
- Massager, Therapeutic, ElectricProduct code ISA · Class I · Physical Medicine · 21 CFR 890.5660
Recalls & enforcement
- Class IIOngoing2024-03-13Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Related
- All facilities operated by E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
- E.M.S. ELECTRO MEDICAL SYSTEMS S.A. (CH)
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →
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