Company: Stellate Systems
Date of Enforcement Report: 5/1/2013
Class ll:
PRODUCT
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 Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers , Recall Number Z-1080-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Stellate Systems, Westmount Minnetonka, MN on 4/6/2009. Voluntary: Firm Initiated recall has been terminated.
VOLUME OF PRODUCT IN COMMERCE
2660 Software licenses
DISTRIBUTION
Nationwide and Internationally
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