Imactis recalls Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

Recall date

February 11, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1264-2021

FDA classification

Class II

Brand / firm

Imactis

Sold / distributed

NJ, NY, WI

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100