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.
Recall
- Recall Number
- Z-0540-2022
- Event Number
- 89306
- Firm
- DIXI MEDICAL USA
- FEI Number
- 3014527920
- Product Code
- GZL
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 9, 2021
- Terminated
- September 8, 2023
- Address
- 11910 Fox Ridge Dr, Plymouth, MI, 48170-2877
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.
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Dixi Medical issued Urgent Medical Device Letter on 12/9/21. Letter states reason for recall, health risk and action to take: 1. Examine your inventory for the affected product. Any available stock must be quarantined immediately and placed in a secure location to prevent further usage. 2. Please use the response form to record and return the stock back to the manufacturer. 3. The returned stock will be replaced with compliant products. 4. Please complete and return the attached Customer Response Form to Ann Cirner, [email protected] (248)845-3494, even if you do not have affected product on hand. 5. Please forward this information to all your staff that may use the MICRODEEP during a SEEG procedure in your healthcare facility. 6. If you have further distributed the product, please forward this notification to any downstream accounts. The removal and return of affected products will be carried out by the hospital staff. Your assistance is appreciated and necessary to prevent a potential patient harm. If you have any questions, call Ann Cirner, [email protected] (248)845-3494
US Nationwide distribution.
345 units