QUANTUM SURGICAL SAS EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a recall — FDA Z-1927-2025
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Overview of recall records associated with QUANTUM SURGICAL SAS, including dates, categories and classifications where available.
Classification mix: Class II: 2.
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
This page summarizes recall records in which the official source identifies QUANTUM SURGICAL SAS as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.