Recall Z-1080-2013— Stellate Systems

Name: FDA recall Z-1080-2013
Creator: U.S. Food and Drug Administration
Published: 2009-04-06

Class II · Terminated

Class II FDA medical device recall by Stellate Systems, initiated 2009-04-06, terminated 2013-04-22. It names 2 FDA 510(k) clearances: K083577, K010728. 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 ,. 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: Stellate Systems
Classification: Class II
Status: Terminated
Initiated: 2009-04-06
Terminated: 2013-04-22
Firm location: Westmount, Canada

510(k) clearances named in this recall

2 on FDA's record

K083577 — HARMONIE SYSTEMStellate Systems·cleared 2011-08-29
K010728 — HARMONE-SCHWARZER EEG SYSTEMStellate Systems·cleared 2001-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 ,

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.