BEUDAMED
    FDA Recall 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 · Initiated May 8, 2008

    Recall

    Recall Number
    Z-1725-2013
    Event Number
    65148
    Firm
    SagaTech Electronics, Inc.
    FEI Number
    3003081035
    Product Code
    MNR
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 8, 2008
    Posted
    July 11, 2013
    Terminated
    July 22, 2013
    Address
    1515 Highfield Crescent SE, 9, Calgary Canada Alberta

    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.

    Action

    SagaTech Electronics Inc, sent a letter to their Customers dated May 2008. The letter identified the product the problem and the action needed to be taken by the customer. Please take particular attention when cleaning these sensors by holding the cable somewhere in the middle and clean towards each end. This should become standard practice with all sensors to prolong their lifespan. If you have further questions please call (403) 228-4214 ext. 234.

    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