Intel-GE Care Innovations LLC: 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.

Recall number

Z-1703-2012

Recalling firm

Intel-GE Care Innovations LLC

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.

Status

Terminated

Initiated

2011-08-01

Posted

2012-06-05

Terminated

2012-06-05

Reason

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

Root cause

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

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

IQA

Firm FEI

3008850109

Firm city

Roseville

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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