BEUDAMED
    FDA Enforcement Class II Terminated

    QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.

    Recall: Z-0877-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0877-2013
    Event ID
    63957
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intel-GE Care Innovations LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    December 16, 2012
    Classification Date
    February 22, 2013
    Termination Date
    February 26, 2013
    Address
    3721 Douglas Blvd Ste 100, N/A, Roseville, CA, 95661-4243, United States

    Description

    QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.

    Reason

    Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered.

    Code Info

    All units of this model.

    Distribution

    Nationwide Distribution.

    Quantity

    19 units