{
  "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": "Burlington",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76014",
      "recalling_firm": "Infraredx, Inc.",
      "address_1": "34 3rd Ave",
      "address_2": "N/A",
      "postal_code": "01803-4414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US including MI and Internationally to South Korea",
      "recall_number": "Z-0940-2017",
      "product_description": "TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography  The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views",
      "product_quantity": "7 units",
      "reason_for_recall": "Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicating the presence of lipid core plaques) was horizontally-oriented",
      "recall_initiation_date": "20161215",
      "center_classification_date": "20170103",
      "termination_date": "20181009",
      "report_date": "20170111",
      "code_info": "Serial Numbers:  MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007  and  12718M00009 (spare laser assembly)"
    }
  ]
}