DIXI MEDICAL USA Recall 89306
Description: 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.
DIXI MEDICAL USA Recall 89306 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0537-2022 |
| Event ID | 89306 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 2720 units |
| Recall Reason | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Device Classification | 20220209 |
| Device Code Info | All lots UDI: 03664539000077 |
| Center Classification Date | 20220128 |
| Recall Initiation Date | 20211209 |
| Recalling Firm | DIXI MEDICAL USA |
| Initial Notification | Letter |
| Similar To |