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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65031
Product Type Devices
Status Ongoing
Recalling Firm Intel-GE Care Innovations LLC
City Roseville
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-04
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern US and Great Britain

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. US  QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK  QuietCare: QCE200403, v.02; QCE200403, v.03 Class II Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. 1722S; 99 Out of US Z-1375-2013
QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked: Facility Server QC101601 Class II Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. 46 Z-1374-2013
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