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.
FDA Recall Z-0487-2012 · Posted 2012-01-11
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Recalling FirmStellate Systems
Recall StatusTerminated
Product CodeGWQ
Date Initiated2009-04-16
Date Terminated2011-12-27
Product Quantity1,041 units
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.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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