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U.S. Department of Health and Human Services

Class 2 Device Recall Harmonie software versions 5.1 uo to 6.2e :

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  Class 2 Device Recall Harmonie software versions 5.1 uo to 6.2e : see related information
Date Initiated by Firm April 06, 2009
Date Posting Updated April 22, 2013
Recall Status1 Terminated 3 on April 22, 2013
Recall Number Z-1080-2013
Recall Event ID 64594
510(K)Number K010728  K083577  
Product Classification Full-montage Standard Electroencephalograph - Product Code GWQ
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 ,

Code Information Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP, Model HSYS-REC-DUO-PPC, Model HSYS-REC-DUO-PPC, Models HSYS-RDR-D, HSYS-RDR-T
Recalling Firm/
Manufacturer
Stellate Systems
345 Victoria Avenue, Suite 300
Westmount Canada
Manufacturer 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.
FDA Determined
Cause 2
No Marketing Application
Action 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.
Quantity in Commerce 2660 Software licenses
Distribution Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, DE, FL, HI, IA, IN, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, OR, PA, RI, SC, TX, VA, VT, WI, WV, and WY; and the countries of: Argentina, Australia, Bahrain, Brasil, Canada, China, Denmark, Finland, France, Germany, Greece, Haiti, Hong Kong, Hungary, Indonesia, Iran, Israel, Italy, Japan, Korea, KSA, Mexico, Netherlands, Norway, Pakistan, Portugal, Rep. DE Panama, Saudi Arabia, Spain, Switzerland, Taiwan ROC, Thailand, Turkey, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GWQ and Original Applicant = STELLATE SYSTEMS
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