Medtronic StealthStation S8 Software Version 2.0 Risk: Surgical Planning Data Shift
Medtronic recalls StealthStation S8 software versions 2.0 and 2.0.1 due to potential surgical planning data shifting. Affected units may require software update or replacement to prevent errors in neurosurgery or ENT procedures.
Lower-risk recall
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
Contact the company
What happened, in plain English
Medtronic is recalling StealthStation S8 software versions 2.0 and 2.0.1 because a software issue could cause surgical planning data to shift unexpectedly. This might lead to errors during neurosurgery or ENT procedures if the software is used without correction. Read more at govinfonow.com/recall/57224-medtronic-stealthstation-s8-software-version-2-0-risk-surgical-planning.
Source Summary by GovInfoNow · govinfonow.com/recall/57224-medtronic-stealthstation-s8-software-version-2-0-risk-surgical-planning · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0188-2024
Cite this page
“Medtronic StealthStation S8 Software Version 2.0 Risk: Surgical Planning Data Shift.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57224-medtronic-stealthstation-s8-software-version-2-0-risk-surgical-planning. Based on FDA recall #Z-0188-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0188-2024%22&limit=1).
Why it’s dangerous
A software anomaly in versions 2.0 and 2.0.1 could cause surgical planning data to shift to an unintended location. This might lead to incorrect anatomical structures being identified during procedures, potentially causing errors in neurosurgery or ENT surgeries.
Who’s affected
Surgical teams using Medtronic StealthStation S8 systems with software versions 2.0 or 2.0.1 are affected. Neurosurgeons and ENT specialists using the system for procedures are most at risk.
How to tell if you have this one
Check if your StealthStation S8 system has software version 2.0 or 2.0.1. The model number is 9735762, and the system was sold with the UDI-DI code 00763000532123.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Software Version
Verify your StealthStation S8 system's software version by checking the model number and UDI-DI code.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
FDA distribution: “Worldwide Distribution: U.S. (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0188-2024 (September 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0188-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.