Health product recall

StealthStation S8 Application

Last updated

Summary

Product
StealthStation S8 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 Application More than 10 numbers, contact manufacturer. 9735762

Issue

Medtronic is writing to customers to inform them of an issue associated with the StealthStation™ S8 application, and specifically the display that shows the "distance to target" or "tip stop point" measurements. There is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation. In certain situations, this anomaly could lead to incorrect data being displayed during surgical procedures.

Recall Start Date: April 10, 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 II
Identification number
RA-75913

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