Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 Recalled by Imactis Due to Defect in the mechanical assembly of the needle...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Imactis directly.
Affected Products
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Quantity: 105 kits
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 3 states: NJ, NY, WI
About Imactis
Imactis has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report