Imactis: Medical Device Recall in 2021 - (Recall #: Z-1264-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 11, 2021

Date Posted: March 24, 2021

Recall Number: Z-1264-2021

Event ID: 87391

Reason for Recall:

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

Status: Terminated

Product Quantity: 105 kits

Code Information:

Lots #: 20060001, 20060005 UDI-DI: B681I101002

Distribution Pattern:

NJ, NY, WI

Voluntary or Mandated:

Voluntary: Firm initiated