Health product recall

Stealthstation S8 Application

Last updated

Summary

Product
Stealthstation S8 Application
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Stealthstation S8 Application

N30873774
N30890766
0011209427
N30873773

9735762

Issue

Medtronic identified a software anomaly that resulted in the surgical plan data shifting location(s) after the reference exam was changed. For this anomaly to occur, a pre-merge or diffusion-merge must have been used as the initial reference exam.

Recall start date: September 26, 2023

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-74432

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