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Twisted Pair Needle Electrode
SGM d.o.o. · Model 003-400124-3 · UDI-DI 00852373007083
1
510(k) clearances
150
Adverse events
2
Recalls
39
Facilities
Description
Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside one package, to preserve sterility of the product. Used as a set for one medical operation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-09 | Technomed Europe | Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU. |
| 2007-04-12 | Chalgren Enterprises Inc | Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility. |
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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.