Z-1703-2012

Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name...

Name: Z-1703-2012 Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name...
Creator: Intel-GE Care Innovations LLC
Published: 2011-08-01
License: https://open.fda.gov/license/

Intel-Ge Care Innovations, LLC / initiated 2011-08-01 / Terminated / root cause: manufacturing process

FDA source

Intel-GE Care Innovations LLC began a recall of Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control, Powered. -- Firm on... on 2011-08-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1703-2012
Status: Terminated
Initiated: 2011-08-01
Posted: 2012-06-05
Terminated: 2012-06-05
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.
Product code: IQA System, Environmental Control, Powered
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
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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.

Product code IQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)