U.S. FDA — Device Enforcement · Switzerland · 2018-07-26 · Class II
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Reported risk: When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial portion of the plan.
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