Medtronic StealthStation S8 App versions 1.3.0 and 1.3.2: Software issues may cause
Medtronic recalls StealthStation S8 App versions 1.3.0 and 1.3.2 (Model # 9735762) due to two software anomalies that can cause images to appear flipped or fail to display warnings during spine procedures.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Medtronic is recalling specific versions of its StealthStation S8 App software (1.3.0 and 1.3.2) because they have two software issues that could cause images to appear flipped or fail to show warnings during spine procedures. This may affect surgical precision and safety. Read more at govinfonow.com/recall/54175-medtronic-stealthstation-s8-app-versions-1-3-0-and-1.
Source Summary by GovInfoNow · govinfonow.com/recall/54175-medtronic-stealthstation-s8-app-versions-1-3-0-and-1 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0050-2025
Cite this page
“Medtronic StealthStation S8 App versions 1.3.0 and 1.3.2: Software issues may cause.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54175-medtronic-stealthstation-s8-app-versions-1-3-0-and-1. Based on FDA recall #Z-0050-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0050-2025%22&limit=1).
Why it’s dangerous
The software has two issues: 1) During lateral orientation radiographic images, information may appear flipped (180 degrees) when using the system. 2) When using CT+Fluoroscopy images with slice spacing greater than 2mm, the system doesn't display a warning message indicating the slice spacing is not optimal. These issues could lead to less precise surgical procedures.
Who’s affected
Medical professionals using the StealthStation S8 App software with the specified model numbers for spine procedures. The risk is low as these are software issues that don't cause immediate harm but could affect surgical accuracy.
How to tell if you have this one
Check if your StealthStation S8 App is version 1.3.0 or 1.3.2 with the model number 9735762. The product includes specific serial numbers listed in the recall notice.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Software Version
Verify your StealthStation S8 App version is 1.3.0 or 1.3.2 with model number 9735762.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 37 states.
FDA distribution: “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, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to do anything?
Check your software version. If affected, contact Medtronic for updates or corrections.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0050-2025 (August 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0050-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.