FDA-Device2013-05-01Class II
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 Suppressi
Stellate Systems
Hazard
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.
Sold states
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.
Affected count
2660 Software licenses
Manufactured in
345 Victoria Avenue, Suite 300, Westmount, Canada
Products
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 ,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1080-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief