FDA-Device2026-09-09Class IIPROCESSING DEFECT
Medos Velys Robotic-Assist Station recalled for unintended arm movement risk
What this means
A software issue in the robotic controller of the Medos Velys Enabling Tech Robotic-Assist Station may cause the robotic arm to move unexpectedly during bone preparation or instrument positioning in orthopedic surgery. This affects 29 devices nationwide.
- If your facility uses this device, contact Medos International Sarl for a software update or further instructions.
- Do not use affected units until the software issue is resolved.
- Check the serial number list provided by the FDA to confirm if your station is affected.
The agency's original wording
Hazard
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
Affected count
29 stations
Manufactured in
Chemin Blanc 36, N/A, Le Locle, N/A, Switzerland
Products
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3088-2026Want us to check the next one for you?
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