Stellate Systems: 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

Recalling firm

Stellate Systems

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 ,

Status

Terminated

Initiated

2009-04-06

Posted

2013-04-22

Terminated

2013-04-22

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.

Root cause

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

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.

Lot, serial or model codes

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

510(k) numbers

["K010728","K083577"]

PMA numbers

not on file

Product code

GWQ

Firm FEI

3002808695

Firm city

Westmount

Firm state

not on file

Firm country

Canada

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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