Medos International Sarl: Velys Enabling Tech Robotic-Assist Station REF: 451611001
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medos International Sarl
- Product
- Velys Enabling Tech Robotic-Assist Station REF: 451611001
- Reason / hazard
- Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
- Recall initiated
- 2026-07-23
- Code info
- 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
- Product quantity
- 29 stations
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Le Locle
- State
- N/A
- Country
- Switzerland
- Event id
- 99467
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