FDA Recall: Software issue within robotic controller which may cause unintended movement

Company: Medos International Sarl
Date of Enforcement Report: 9/2/2026
Class: II

PRODUCT

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Recall Number:

Z-3088-2026

REASON:

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

RECALLING FIRM/MANUFACTURER:

Medos International Sarl

VOLUME:

29 stations

DISTRIBUTION:

US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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