eTRAX Needle System Starter Kit 18G Class II Recall - Sensor Programming Error

FDA classified a Class II recall for Civco Medical Instruments' eTRAX Needle System Starter Kit 18G (Part Number 667-152) due to a sensor programming error. The error in inspection and programming of the eTRAX needle sensor for Aurora trackers creates a potential for the needle tip position to be incorrectly identified on the user interface, which could lead to navigational errors during medical procedures.

Healthcare providers and facilities that have distributed or used these devices in Ohio, Pennsylvania, Washington, and China should immediately identify affected inventory, cease use of potentially miscalibrated devices, and contact Civco Medical Instruments for return/replacement instructions. The incorrect needle tip position display presents a safety concern for procedures relying on accurate sensor tracking.