Medos International Sarl: Velys Enabling Tech Robotic-Assist Station REF: 451611001

Is my product affected?

Velys Enabling Tech Robotic-Assist Station REF: 451611001

• UPC 10705034645995

Check against the official notice below — it lists the full affected range.

Hazard

Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

Details from the source

Reason for recall: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. Distribution: US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA. Quantity: 29 stations Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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