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U.S. Department of Health and Human Services

Class 3 Device Recall QuietCare

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  Class 3 Device Recall QuietCare see related information
Date Initiated by Firm August 01, 2011
Date Posted June 05, 2012
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-1703-2012
Recall Event ID 61834
Product Classification System, environmental control, powered - Product Code IQA
Product Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control, Powered. -- Firm on label: Manufacturer Living Independently Group, Inc., A wholly owned subsidiary of General Electric Company, PO Box 1466, New York, NY 10116 USA, 1-866-772-8243 --- The system is a passive behavior-monitoring device. QuietCare uses strategically placed, unobtrusive, passive wireless infrared pyroelectric sensors in the senior's residence to detect their movement. Data from these sensors are sent to a base station that periodically transmits the information to a centralized secure file server through standard phone lines over a toll-free number. Sophisticated algorithms analyze the data, learning each individual's normal patterns of behavior. When the system detects significant deviations from these baselines it automatically alerts designated caregivers. QuietCare also generates alerts of late wake-ups, potential bathroom falls and if household temperatures become dangerously low or high. The behavioral changes that the system tracks can often serve as subtle indicators of the potential emerging health problems. These changes include: nighttime bathroom usage, entering or exiting the bedroom at a different time than usual, change in the number of times the refrigerator door is opened/closed change in the number of times the medicine cabinet door is opened/closed. The intended users of the QuietCare device are the caregivers at the Assisted Living Facilities and Independent Living Facilities. The monitored individuals (seniors) do not actively operate the device and the device function is not dependent upon the senior resident's ability to use the device. --- Class 2 device, 510(k) exempt, Device Listing Number D117156.
Code Information Affected Hardware Serial Numbers: 020685, 020267, 021542, 018880, 021585, 024179, 022003, 020232, 020272, 024148, 024252, 017044, 017648, 023385, 018651, 024376, 023988, 018567, 017151, 018460, 026701, 021130, 021366, 017735, 019229, 026371, 026317, 018010, 026334, 017471, 019952, 026293, 019476, 026292, 017089, 019953, 026335, 018630, 026439, 026378, 026260, 026239, 022050, 019477, 018379, 024346, 018224, 023936, 020421, 022129, 022216, 018543, 026760, 024270, 021649, 021918, 023465, 023531, 020716, 018962,  020718.           
Recalling Firm/
Manufacturer		 Intel-GE Care Innovations LLC
3721 Douglas Blvd Ste 100
Roseville CA 95661-4243
For Additional Information Contact Customer Support Department
916-356-8438
Manufacturer Reason
for Recall		 On 7/29/11, the QuietCare production system experienced a partial outage from about 15:00 hours until 22:30. During the engineering investigation into the cause of the service disruption, it was discovered that some residents did not have the wander and night motion features properly activated, and alerts were not being transmitted. Failure to generate alerts in a timely manner could result in a
FDA Determined
Cause 2		 Employee error
Action Intel-GE Care Innovations sent an "URGENT FIELD NOTIFICATION" e-mail dated August 12, 2011 to all affected customers. The notification identifies the product and problem. No action is required by the customers. Contact Customer Service at (866) 772-8243 for questions regarding this notice.
Quantity in Commerce 61 units were identified as affected
Distribution Nationwide Distribution-USA (nationwide) including the states of Arizona, California, Connecticut, Idaho, Illinois, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas, and Utah.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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