Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical Recalled by Medtronic Navigation, Inc. Due to Medtronic Navigation, Inc. has initiated a field correction...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Navigation, Inc. directly.
Affected Products
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Quantity: 572
Why Was This Recalled?
Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
Where Was This Sold?
Worldwide Distribution.
About Medtronic Navigation, Inc.
Medtronic Navigation, Inc. has 91 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report