Reported May 15, 2024 · Ongoing
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid…
Medtronic Navigation, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 200 Medtronic Drive · Lafayette, CO · 80026
Is this the product you have?
- Stealth S8 Clinical Software Application
- REF9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures
- Lot codes and dates
- UDIs
00763000234867007630001252950076300006317700643169865341/
- Software Versions
1.2.01.1.01.0.31.0.2and 1.0.1
- UDIs
- Amount recalled
- 3286 applications.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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