BEUDAMED
    FDA Recall 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 · Initiated March 31, 2016

    Recall

    Recall Number
    Z-1992-2016
    Event Number
    73692
    Firm
    Med Tec Inc
    FEI Number
    1000143606
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 31, 2016
    Terminated
    February 3, 2017
    Address
    1401 8th St SE PO Box 320, Orange City, IA, 51041-7463

    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.

    Action

    Civco Medical Solutions sent a "Urgent Field Correction Notice" dated March 31, 2016, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer. The software's other configuration, "All 6 Degrees Protura" does not have the same translational issues. The firm send notification letters on February 23, 2016. In this letter, the Product Manager verified each site's software is configured to this operational mode which operates without the identified problem. In a later and separate notification on March 31, 2016, the firm informed customers that a new software version will be installed to address the problem. No timeframe was given in the letter. For further questions, please call ( 712) 737-8688.

    Distribution

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

    Quantity

    9