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Health Canada Medical devices

StealthStation™ S8 software application

Issued September 4, 2024
Issue
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. Recall start date: August 26, 2024
Hazard description
Performance
Product
Product name
StealthStation™ S8 software application
Reference
ID
RA-75999