medical Class II Updated 2021-03-24

Imactis recalls Impactis NaviKit-stereotaxic accessory for Computed Tomograp

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: NJ, NY, WI
Lot/Code Info: Lots #: 20060001, 20060005 UDI-DI: B681I101002
View official government recall

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