Device 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.
Z-0536-2022
Product summary
- Firm
- DIXI MEDICAL USA
- Event
- Event 89306
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2141 units
- Official record key
device-enforcement:Z-0536-2022
Official wording
Reason: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Code information: All lots UDI: 03664539000053
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
packaging (blister pack) could compromise sterile