{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Westmount",
      "state": "",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64594",
      "recalling_firm": "Stellate Systems",
      "address_1": "345 Victoria Avenue, Suite 300",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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.",
      "recall_number": "Z-1080-2013",
      "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 ,",
      "product_quantity": "2660 Software licenses",
      "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.",
      "recall_initiation_date": "20090406",
      "center_classification_date": "20130422",
      "termination_date": "20130422",
      "report_date": "20130501",
      "code_info": "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",
      "more_code_info": ""
    }
  ]
}