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DEPTHALON
PMT CORPORATION · Model 2104-07-57-012 · UDI-DI 00650551000129
GZL
Prescription
10
510(k) clearances
223
Adverse events (3 deaths)
24
Recalls
24
Facilities
Description
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 54.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
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.