Recall Z-1080-2013 ยท GWQ Full-Montage Standard Electroencephalograph
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 Ox
| Date | Apr 22, 2013 (initiated Apr 6, 2009) |
| Status | Terminated |
| 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 U |
| 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 |
| FDA record | Open on fda.gov |