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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 July 30, 2011
Date Posted May 16, 2012
Recall Status1 Terminated 3 on May 21, 2012
Recall Number Z-1615-2012
Recall Event ID 61719
Product Classification System, environmental control, powered - Product Code IQA
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.
Code Information 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).
Recalling Firm/
Manufacturer		 Intel-GE Care Innovations LLC
3721 Douglas Blvd Ste 100
Roseville CA 95661-4243
For Additional Information Contact Customer Support Department
866-772-8243
Manufacturer 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
FDA Determined
Cause 2		 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.
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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