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Stealthstation s8 application
Official notice
14 Aug 2024
Last checked
14 Aug 2024
An official Health Canada notice concerns Stealthstation s8 application. 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 Published 2024-08-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75913
Official notice
2024-08-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Medtronic Navigation, Stealthstation S8 Application.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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