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U.S. Department of Health and Human Services

Class 2 Device Recall Dixi Medical Microdeep Depth Electrodes

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  Class 2 Device Recall Dixi Medical Microdeep Depth Electrodes see related information
Date Initiated by Firm December 09, 2021
Create Date January 28, 2022
Recall Status1 Terminated 3 on September 08, 2023
Recall Number Z-0540-2022
Recall Event ID 89306
510(K)Number K170959  
Product Classification Electrode, depth - Product Code GZL
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.
Code Information All lots UDI:03664539000114
Recalling Firm/
Manufacturer		 DIXI MEDICAL USA
11910 Fox Ridge Dr
Plymouth MI 48170-2877
Manufacturer Reason
for Recall		 Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
FDA Determined
Cause 2		 Under Investigation by firm
Action 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, ann.cirner@diximedus.com (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, ann.cirner@diximedus.com (248)845-3494
Quantity in Commerce 345 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GZL and Original Applicant = DIXI Medical
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