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sEEG DEPTHALON®
PMT CORPORATION · Model 2102-08-189 · UDI-DI 00650551004844
GZL
Prescription
10
510(k) clearances
223
Adverse events (3 deaths)
24
Recalls
24
Facilities
Description
SEEG, 8 CONTACT, 2MM CONTACT, 26.5MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly p |
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly p |
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly p |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
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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.