Company: Boston Scientific Corporation Date of Enforcement Report: 9/2/2026 Class: II PRODUCT LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7) Recall Number: Z-3082-2026 REASON: There is potential for a delay in AF Burden Alert notification affecting the server software which supports...Read More
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...Read More
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