Recall Z-1264-2021 ยท JAK System, X-Ray, Tomography, Computed
Imactis
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
| Date | Feb 11, 2021 |
| Status | Terminated |
| 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 |
| Root cause | Process control |
| Action | Imactis notified users by visit on 2/11/221 and issued Urgent Medical Device Recall on 2/25/21 via email to consignees. Letter states reason for recall, health risk and action to take: Customers are requested to quarantine any product from the affected NaviKit" lot numbers and return them to Imactis Affected NaviKit lot numbers will be quarantined and removed from the market. New compliant product will be sent to customers to replace the removed lot numbers. As the defect is visually detectable, product will be inspected internally according to an approved procedure and any defective needle |
| Quantity | 105 kits |
| Distribution | NJ, NY, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162314 | IMACTIS CT-Navigation system Imactis, Sas, Apr 24, 2018 |