BEUDAMED
    FDA Enforcement Class I Terminated

    MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. 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-0586-2016 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0586-2016
    Event ID
    72867
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thornhill Research Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 20, 2016
    Initiation Date
    November 19, 2015
    Classification Date
    January 11, 2016
    Termination Date
    April 12, 2019
    Address
    210 Dundas St W Suite 200, N/A, Toronto, N/A, N/A, Canada

    Description

    MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. 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.

    Code Info

    MS201205001, MS201205002, MS201205003, MS201205004, MS201205005, MS201212001, MS201212002, MS201212003, MS201212004, MS201212005, MS201212006, MS201212007, MS201212008, MS201212009, MS201212010, MS201212011, MS201212012, MS201212013, MS201212024, MS201212025, MS201212026, MS201212028, MS201212029, MS201212030, MS201212031, MS201212032, MS201212033, MS201212034, MS201212035, MS201212036, MS201212037, MS201212038, MS201212039, MS201212040, MS201212041, MS201212042, MS201212053, MS201212054, MS201212055, MS201212056, MS201212057, MS201212058, MS201212059, MS201212060, MS201212061, MS201212062, MS201212062, MS201212063, MS201212064, MS201212065, MS201212066, MS201212067, MS201212068, MS201212069, MS201212070, MS201212014, MS201212015, MS201212016, MS201212017, MS201212018, MS201212019, MS201212020, MS201212021, MS201212022, MS201212023, MS201212043, MS201212044, MS201212045, MS201212046, MS201212047, MS201212048, MS201212049, MS201212050, MS201212051, MS201212052, MS201212071, MS201212072, MS201212073, MS201212074, MS201212075, MS201212076, MS201212077, MS201212078, MS201212079

    Distribution

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

    Quantity

    83 units