Stellate Systems 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stellate Systems
Lot Codes / Batch Numbers
Versions 5.1 up to 6.2e
Products Sold
Versions 5.1 up to 6.2e
Stellate Systems is recalling Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC- due to The following implied or stated indications in Stellate labeling with Harmoniae software have not yet been cleared by the Food and Drug Administration. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026