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U.S. Department of Health and Human Services

Class 2 Device Recall Care Innovations QuietCareNetworked product

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  Class 2 Device Recall Care Innovations QuietCareNetworked product see related information
Date Initiated by Firm December 16, 2012
Date Posted February 23, 2013
Recall Status1 Terminated 3 on February 26, 2013
Recall Number Z-0877-2013
Recall Event ID 63957
Product Classification Monitor, bed patient - Product Code KMI
Product QuietCare-Networked product, Facility Server/model: QC101601;

The QuietCare system is intended to detect and analyze residents' movements.
Code Information All units of this model.
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		 Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered.
FDA Determined
Cause 2		 Software design
Action Care Innovations sent a "DEVICE CORRECTION NOTIFICATION" letter dated 12/20/12 to all affected customers. The letter identified the product and problem. Correction was performed remotely by the firm. Contact the firm at 917-232-4775 for questions regarding this notice.
Quantity in Commerce 19 units
Distribution Nationwide Distribution.
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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