Medos Velys Robotic-Assist Station Software Issue May Cause Unintended Arm Movement
Medos recalls Velys Robotic-Assist Station REF: 451611001 due to software issue causing unintended robotic arm movement during bone preparation. Affected units have specific serial numbers listed in the recall notice.
Use caution until it’s fixed
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
What happened, in plain English
Medos is recalling Velys Enabling Tech Robotic-Assist Stations with serial numbers starting with W14316295301 to Y15316690901 because a software issue might cause the robotic arm to move unexpectedly while preparing bones or positioning instruments. This could lead to injury if the arm moves without the user's control. Read more at govinfonow.com/recall/843310-medos-velys-robotic-assist-station-software-issue-may-cause-unintended.
Source Summary by GovInfoNow · govinfonow.com/recall/843310-medos-velys-robotic-assist-station-software-issue-may-cause-unintended · Updated September 16, 2026 · FDA enforcement record: FDA #Z-3088-2026
Cite this page
“Medos Velys Robotic-Assist Station Software Issue May Cause Unintended Arm Movement.” GovInfoNow, updated September 16, 2026. https://govinfonow.com/recall/843310-medos-velys-robotic-assist-station-software-issue-may-cause-unintended. Based on FDA recall #Z-3088-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3088-2026%22&limit=1).
Why it’s dangerous
The software issue in the robotic controller may cause the arm to move unexpectedly during bone preparation or instrument positioning. This could result in unintended movements that might harm the user or the patient if the arm is not under their control.
Who’s affected
Medical professionals using the Velys Robotic-Assist Station for bone surgery are most at risk, particularly those operating the device during procedures where precise instrument placement is critical.
How to tell if you have this one
Check if your Velys Robotic-Assist Station has a serial number starting with W14316295301 to Y15316690901. The product was sold with the reference number REF: 451611001.
- Brand
Medos- Category
Medical device
What to do — step by step
Check for Unintended Movement
If you notice the robotic arm moving unexpectedly during bone preparation or instrument positioning, stop using the device immediately.
Contact Medos for Details
Reach out to Medos International Sarl directly for specific instructions on how to verify if your unit is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
FDA distribution: “US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Delaware, Florida, Illinois, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
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-3088-2026 (July 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3088-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 16, 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.