BEUDAMED
    FDA Enforcement Class II Terminated

    Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.

    Recall: Z-1725-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1725-2013
    Event ID
    65148
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SagaTech Electronics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 17, 2013
    Initiation Date
    May 8, 2008
    Classification Date
    July 11, 2013
    Termination Date
    July 22, 2013
    Address
    9, 1515 Highfield Crescent SE, N/A, Calgary, Alberta, N/A, Canada

    Description

    Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.

    Reason

    The outer jacket is receding away from the black sensor prematurely.

    Code Info

    Model: 1.1 Lot numbers: 13367 and 13710

    Distribution

    Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.

    Quantity

    152 units 77 devices from lot 13367 and 75 devices from lot 13710