Public recall detail

StealthStation™ S8 software application

2024-09-04

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Recall Safety notice
Quick summary

Quick summary: StealthStation™ S8 software application. Date: 2024-09-04.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: StealthStation™ S8 software application. Date: 2024-09-04.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandMedtronic Navigation, Inc
ProductStealthStation™ S8 software application
IssueMedical devices - Performance
Recall classType I
IdentificationRA-75999

Affected products

ProductStealthStation™ S8 software application
LotMore than 10 numbers, contact manufacturer.
Model9735762
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionStealthStation™ S8 software application

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesMedtronic Navigation, Inc. 826 Coal Creek Circle, Louisville, Colorado, United States, 80027
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75999
Background{}
CompaniesMedtronic Navigation, Inc. 826 Coal Creek Circle, Louisville, Colorado, United States, 80027
AudiencesHealthcare
Source updated2024-09-04

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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