Recall Z-1264-2021— Imactis
Class II · Terminated
Class II FDA medical device recall by Imactis, initiated 2021-02-11, terminated 2023-10-05. It names one FDA 510(k) clearance: K162314. Product: Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100. Reason: 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.
- Recalling firm
- Imactis
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-11
- Terminated
- 2023-10-05
- Firm location
- St Martin D Heres, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.