BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0877-2013 · Initiated December 16, 2012

    Recall

    Recall Number
    Z-0877-2013
    Event Number
    63957
    Firm
    Intel-GE Care Innovations LLC
    FEI Number
    3008850109
    Product Code
    KMI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 16, 2012
    Posted
    February 23, 2013
    Terminated
    February 26, 2013
    Address
    3721 Douglas Blvd, Ste 100, Roseville, CA, 95661-4243

    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.

    Action

    Care Innovations sent a "DEVICE CORRECTION NOTIFICATION" letter dated 12/20/12 to all affected customers. The letter identified the product and problem. Correction was performed remotely by the firm. Contact the firm at 917-232-4775 for questions regarding this notice.

    Distribution

    Nationwide Distribution.

    Quantity

    19 units