Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-...
FDA Recall #Z-1080-2013 — Class II — April 6, 2009
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.
Recalling Firm
Stellate Systems — Westmount
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated