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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-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
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
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