BEUDAMED
    FDA Enforcement Class II Terminated

    Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041

    Recall: Z-1992-2016 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1992-2016
    Event ID
    73692
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Med Tec Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    March 31, 2016
    Classification Date
    June 15, 2016
    Termination Date
    February 3, 2017
    Address
    PO Box 320, 1401 8th St SE, Orange City, IA, 51041-7463, United States

    Description

    Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041

    Reason

    When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.

    Code Info

    Versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1)

    Distribution

    Worldwide Distribution - US Distribution including the countries of Switzerland, Germany..

    Quantity

    9