Official recall record

StealthStation™ S8 software application

Health Canada — Medical Devices · 2024-09-04 · CanadaType I

Issuing authority: Health Canada — Medical Devices
Published: 2024-09-04
Country of alert: Canada
Alert level: Type I
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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