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.
FDA Recall Z-1615-2012 · Posted 2012-05-16
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Recalling FirmIntel-GE Care Innovations LLC
Recall StatusTerminated
Product CodeIQA
Date Initiated2011-07-30
Date Terminated2012-05-21
Product Quantity82 units affected by the outage: Domestic - 80 units, Foreign - 2 units
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
Firm 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.
Root Cause
Employee error
Distribution Pattern
Worldwide distribution - USA and the United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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