Stellate Systems Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA.

Recommended Action

Per FDA guidance

Stellate sent an "DEVICE CORRECTION" letter dated April 6, 2009, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were instructed to check the product code referenced in the service manual to verify if your system is affected and check in "Help" & "About Harmonie" in the menu to determine the software version on these systems. Stellate will shortly release updates to disable the noted features that were present in your particular version of the Harmonie software and revise labeling and Instructions for Use. All customers in possession of an affected system will be contacted by our Customer Support team to set up an appointment for installation of the updated version. If you have any questions or concerns regarding this notification, please do not hesitate to call our customer support line at 1-888-742-1306.