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Imactis recalls Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Recalled March 24, 2021 · FDA recall Z-1264-2021 · Imactis
Hazard
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 Class II
Units
105 kits
Sold at
NJ, NY, WI
Description
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
Product
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Manufacturer(s)
Imactis
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →