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U.S. Department of Health and Human Services

Class 2 Device Recall QuietCare

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  Class 2 Device Recall QuietCare see related information
Date Initiated by Firm April 04, 2013
Date Posted May 24, 2013
Recall Status1 Terminated 3 on June 04, 2013
Recall Number Z-1375-2013
Recall Event ID 65031
Product Classification System, environmental control, powered - Product Code IQA
Product QuietCare.

Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Code Information US  QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK  QuietCare: QCE200403, v.02; QCE200403, v.03 
Recalling Firm/
Manufacturer		 Intel-GE Care Innovations LLC
3721 Douglas Blvd Ste 100
Roseville CA 95661-4243
For Additional Information Contact Bonnie Norman
916-356-8438
Manufacturer Reason
for Recall		 Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
FDA Determined
Cause 2		 Software design
Action Care Innovations contacted their customers by phone and e-mail regarding the potential problems and fixes on April 4, 17, and 23, 2013. The information provided stated the product, problem, and actions to be taken by the customers. Contact Technical Support at 855-885-2273 for questions regarding this issue.
Quantity in Commerce 1722S; 99 Out of US
Distribution US and Great Britain
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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