Medos Velys Robotic-Assist Station recalled for unintended arm movement risk
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Velys Enabling Tech Robotic-Assist Station REF: 451611001
- Sold in
- Nationwide
- Made for
- Adults
Details
- Units affected
- 29 stations
- Illnesses reported
- None reported
- Manufactured in
- Chemin Blanc 36, N/A, Le Locle, N/A, Switzerland
- Classification
- Class II
- Recall number
- Z-3088-2026
In the FDA's words
- Description
- Velys Enabling Tech Robotic-Assist Station REF: 451611001 Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. UDI: 10705034645995/Serial Numbers: W14316295301 W15316297501 W15316298001 W17316322901 W17316323301 W21316347401 W21316347501 W21316347601 W21316347801 W21316347901 W21316348001 W22316365801 W34316479001 W34316479101 W34316479201 W34316479301 W34316479401 W34316479601 W34316479801 W34316480001 W34316480101 W49316554301 W51316597001 W51316597101 Y03316603601 Y03316603701 Y03316603801 Y07316625901 Y15316690901 Distribution: US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA. Affected quantity: 29 stations
- Hazard
- Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.