BEUDAMED
    FDA Enforcement Class II Terminated

    QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

    Recall: Z-1375-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1375-2013
    Event ID
    65031
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intel-GE Care Innovations LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 5, 2013
    Initiation Date
    April 4, 2013
    Classification Date
    May 24, 2013
    Termination Date
    June 4, 2013
    Address
    3721 Douglas Blvd Ste 100, N/A, Roseville, CA, 95661-4243, United States

    Description

    QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

    Reason

    Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.

    Code Info

    US  QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK  QuietCare: QCE200403, v.02; QCE200403, v.03

    Distribution

    US and Great Britain

    Quantity

    1722S; 99 Out of US