openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
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event_date_initiated coverage
June 01, 1997–June 30, 2026
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device · product 1 of 1
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
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
These labels are deterministic app interpretations, not FDA categories.
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
