BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1374-2013 · Initiated April 4, 2013

    Recall

    Recall Number
    Z-1374-2013
    Event Number
    65031
    Firm
    Intel-GE Care Innovations LLC
    FEI Number
    3008850109
    Product Code
    IQA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2013
    Posted
    May 24, 2013
    Terminated
    June 4, 2013
    Address
    3721 Douglas Blvd, Ste 100, Roseville, CA, 95661-4243

    Description

    QuietCare-Networked. 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.

    Action

    Care Innovations contacted their customers by phone and e-mail regarding the potential problems and fixes on April 4, 17, and 23, 2013. The information provided stated the product, problem, and actions to be taken by the customers. Contact Technical Support at 855-885-2273 for questions regarding this issue.

    Distribution

    US and Great Britain

    Quantity

    46