DIXI MEDICAL USA Recall: The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Elec
DIXI MEDICAL USA Recall: The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Elec is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: DIXI MEDICAL USA; Product: The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8
| Recalling firm | DIXI MEDICAL USA |
|---|---|
| Product | The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. |
| Reason for recall | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Nationwide distribution. |
| Recall initiated | 20211209 |
| Recall number | Z-0541-2022 |
| Category | device |
| State | MI |
| Country | United States |
$29/mo
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