BEUDAMED
    FDA Recall Terminated

    MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.

    Recall: Z-0587-2016 · Initiated November 19, 2015

    Recall

    Recall Number
    Z-0587-2016
    Event Number
    72867
    Firm
    Thornhill Research Inc
    FEI Number
    3005803793
    Product Code
    BTL
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 19, 2015
    Posted
    January 11, 2016
    Terminated
    April 12, 2019
    Address
    210 Dundas St W, Toronto Canada Suite 200

    Description

    MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.

    Reason

    Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.

    Action

    Thornhill Research sent a Recall Notification letter dated December 15, 2015 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to update their device software. For questions customers were instructed to call 416-597-1325.

    Distribution

    Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.

    Quantity

    178 units