Medtronic Navigation, Inc. 2024-10-16 Health serious FDA
Health · FDA · Recall #FDA-Z-0050-2025
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation… Recall
Issued October 16, 2024 · Medtronic Navigation, Inc.
In October 2024, Medtronic Navigation, Inc. recalled the StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
What you should do
- 1 Stop using StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Navigation, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Medtronic Navigation, Inc.
- Category
- Health
- Recall date
- October 16, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, M
- Recall number
- FDA-Z-0050-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Navigation, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.