Z-0487-2012

Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT...

Name: Z-0487-2012 Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT...
Creator: Stellate Systems
Published: 2009-04-16
License: https://open.fda.gov/license/

Stellate Systems / initiated 2009-04-16 / Terminated / root cause: labeling and UDI

FDA source

Stellate Systems began a recall of 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... on 2009-04-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0487-2012
Status: Terminated
Initiated: 2009-04-16
Posted: 2012-01-11
Terminated: 2011-12-27
Recalling firm: Stellate Systems
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.
Product code: GWQ Full-Montage Standard Electroencephalograph
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.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
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.
Product codes and lots: Versions 5.1 up to 6.2e

Product code GWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)