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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 Recall
Care Innovations QuietCareNetworked product
see related information
Date Posted February 23, 2013
Recall Status1 Terminated 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, California 95661-4243
Consumer Instructions No consumer action necessary
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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