Imactis 20 Rue Du Tour De L Eau St Martin D Heres France Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 holders will be sorted and replaced with compliant ones. Refurbished NaviKit" product will not be sold to customers. Your IMACTIS representative for questions: Robert Hornak (VP Sales, North America) - 205-542-1486 (Cell) - 205-542-1486 (cell) Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time

Distribution

As reported by FDA

NJ, NY, WI