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U.S. Department of Health and Human Services

Class 2 Device Recall The IMACTIS CTNAVIGATION system

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  Class 2 Device Recall The IMACTIS CTNAVIGATION system see related information
Date Initiated by Firm February 11, 2021
Create Date March 16, 2021
Recall Status1 Terminated 3 on October 05, 2023
Recall Number Z-1264-2021
Recall Event ID 87391
510(K)Number K162314  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Impactis NaviKit-stereotaxic accessory for Computed Tomography systems

Reference # I10100
Code Information Lots #: 20060001, 20060005 UDI-DI: B681I101002
Recalling Firm/
Manufacturer		 Imactis
20 Rue Du Tour De L Eau
St Martin D Heres France
For Additional Information Contact Robert HORNAK
631-6936041
Manufacturer Reason
for Recall		 Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation causing an inaccurate needle position which could cause damage to organs or vasculature adjacent to the trajectory
FDA Determined
Cause 2		 Process control
Action Imactis notified users by visit on 2/11/221 and issued Urgent Medical Device Recall on 2/25/21 via email to consignees. Letter states reason for recall, health risk and action to take: Customers are requested to quarantine any product from the affected NaviKit" lot numbers and return them to Imactis Affected NaviKit lot numbers will be quarantined and removed from the market. New compliant product will be sent to customers to replace the removed lot numbers. As the defect is visually detectable, product will be inspected internally according to an approved procedure and any defective needle holders will be sorted and replaced with compliant ones. Refurbished NaviKit" product will not be sold to customers. Your IMACTIS¿ representative for questions: Robert Hornak (VP Sales, North America) - 205-542-1486 (Cell) - 205-542-1486 (cell) Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time
Quantity in Commerce 105 kits
Distribution NJ, NY, WI
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 = JAK and Original Applicant = IMACTIS, SAS
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