Health product recall

StealthStation™ S8 software application

Last updated

Summary

Product
StealthStation™ S8 software application
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

StealthStation™ S8 software application

More than 10 numbers, contact manufacturer.

9735762

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies

Medtronic Navigation, Inc.

826 Coal Creek Circle, Louisville, Colorado, United States, 80027

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75999

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