Z-1615-2012

QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02...

Name: Z-1615-2012 QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02...
Creator: Intel-GE Care Innovations LLC
Published: 2011-07-30
License: https://open.fda.gov/license/

Intel-Ge Care Innovations, LLC / initiated 2011-07-30 / Terminated / root cause: manufacturing process

FDA source

Intel-GE Care Innovations LLC began a recall of QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living... on 2011-07-30. The reason FDA records is "The QuietCare production system experienced a partial outage on 7/29/11. As a result of the partial outage, some monitoring data about residents' movements was not processed in the production system, and alerts were...". 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-1615-2012
Status: Terminated
Initiated: 2011-07-30
Posted: 2012-05-16
Terminated: 2012-05-21
Recalling firm: Intel-Ge Care Innovations, LLC
Product: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Product code: IQA System, Environmental Control, Powered
Reason for recall: The QuietCare production system experienced a partial outage on 7/29/11. As a result of the partial outage, some monitoring data about residents' movements was not processed in the production system, and alerts were therefore not sent to caregivers. The problem was identified and corrected and the unprocessed data was recovered and processed. However, because of the time lag in processing, a fe
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Initial notification to the affected facilities was done by telephone or email on 7/30/11. This was followed up with Urgent Field Notification letters to the customers on 8/12/11 via e-mail. For questions, customers were instructed to contact Customer Support at 1 (866) 772-8243.
Quantity in commerce: 82 units affected by the outage: Domestic - 80 units, Foreign - 2 units
Distribution: Worldwide distribution - USA and the United Kingdom.
Product codes and lots: Affected Serial Numbers: liqc.018778, liqc.020447, liqc.020428, liqc.024472, liqc.027039, liqc.024195, liqc.026718, liqc.023495, liqc.027065, liqc.024252, liqc.018722, liqc.024377, liqc.019808, liqc.017029, liqc.017310, liqc.026701, liqc.024190, liqc.019075, liqc.027351, liqc.023253, liqc.019497, liqc.019215, liqc.019217, liqc.017965, liqc.020530, liqc.024293, liqc.021530, liqc.026353, liqc.017900, liqc.019915, liqc.018447, liqc.021086, liqc.027072, liqc.023241, liqc.018169, liqc.017876, liqc.022049, liqc.026409, liqc.018126, liqc.019519, liqc.017579, liqc.018271, liqc.017531, liqc.017532, liqc.018255, liqc.023888, liqc.023340, liqc.023343, liqc.023342, liqc.018534, liqc.018536, liqc.018256, liqc.017532, liqc.019582, liqc.021064, liqc.020981, liqc.021944, liqc.021764, liqc.021284, liqc.017741, liqc.017738, liqc.024298, liqc.026760, liqc.027063, liqc.022321, liqc.022320, liqc.020843, liqc.022009, liqc.026620, liqc.026643, liqc.026456, liqc.021428, liqc.021402, liqc.022054, liqc.019577, liqc.023782, liqc.023710, liqc.023708, liqc.019360, liqc.017682, liqc.021670, liqc.022983 (UK), liqc.022846 (UK).

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)