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U.S. Department of Health and Human Services

Class 2 Device Recall Harmonie Software

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 Class 2 Recall
Harmonie Software
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on December 27, 2011
Recall Number Z-0487-2012
Recall Event ID 56540
Premarket Notification
510(K) Number
K010728 
Product Classification Full-Montage Standard Electroencephalograph - Product Code GWQ
Product Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC-LT2; HSYS-REC-EAMP) Harmonie-S Sleep System (Model HSYS-REC-DUO) VITA/ICU Neurological Monitoring System (Model HSYS-REC-DUO-PPC) Harmonie{-S}{-E} Readers (Models HSYS-RDR-D, HSYS-RDR-T). Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations.
Code Information Versions 5.1 up to 6.2e
Recalling Firm/
Manufacturer
Stellate Systems
345 Victoria Avenue, Suite 300
Westmount
Manufacturer Reason
for Recall
The following implied or stated indications in Stellate labeling with Harmoniae software have not yet been cleared by the Food and Drug Administration (FDA) for sale in the United States of America.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Stellate Systems sent a "DEVICE CORRECTION" letter dated April 6, 2009 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The firm provided information on how to verify if customers had the affected product. Software updates will be available to all customers in possession of the affected product. Customers were instructed to call the Customer Support line at 1-888-742-1306 with any questions or concerns they may have regarding the notification.
Quantity in Commerce 1,041 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Denmark, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Norway, Rep. DE Panama, Spain, Switzerland, Taiwan ROC, and Turkey.
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.
510(K) Database 510(K)s with Product Code = GWQ and Original Applicant = STELLATE SYSTEMS
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