Recall Z-1734-2026 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Civco Medical Instruments Co. Inc.
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
| Date | Apr 1, 2026 (initiated Mar 2, 2026) |
| Status | Open, Classified |
| Reason | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. |
| Root cause | Software change control |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated 3/2/26 was sent to customers. Actions to be taken by the Customer/User: CIVCO requests that you check your inventory for any eTRAX Needle Sensor for Aurora Trackers and complete the supplied response letter for the appropriate action. Please contact your distribution partner to return any existing inventory, or report its destruction by completing the attached response form. Please complete the enclosed response form even if you do not have any eTRAX Needle Sensor for Aurora Trackers remaining in your inventory to assist in our reconc |
| Quantity | 20 units |
| Distribution | US States: OH, PA, WA. China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092619 | ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER Civco, Nov 13, 2009 |