Safety Alerts

Health Canada has posted a medical device safety alert concerning Medtronic Navigation Inc StealthStation S8 system [HKMD No.: 210371].

According to Health Canada, Medtronic has identified the following two software anomalies in StealthStation S8 software application versions 1.3.0 and 1.3.2 that can occur within a spine procedure.

1. When lateral orientation radiographic images are taken using a navigation-enabled Ziehm Vision FD Vario 3D C-arm, the navigation orientation information appears flipped when displayed by the StealthStation S8 system.
2. When using CT + fluoroscopy images with a slice spacing thickness greater than 2 mm, the system does not display a pop up message indicating the slice spacing is not optimal. Navigation remains accurate in this situation.

For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/stealthstationtm-s8-software-application

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 05 Sep 2024