{
  "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": "Cleveland",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69082",
      "recalling_firm": "Philips Medical Systems (Cleveland) Inc",
      "address_1": "595 Miner Rd",
      "address_2": "N/A",
      "postal_code": "44143-2131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Distribution to the states of :  AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Canada, Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Luxembourg, Mexico, Netherlands, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and UK.",
      "recall_number": "Z-0197-2016",
      "product_description": "GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.",
      "product_quantity": "264 units",
      "reason_for_recall": "The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.",
      "recall_initiation_date": "20080501",
      "center_classification_date": "20151102",
      "termination_date": "20151106",
      "report_date": "20151111",
      "code_info": "Model Name Model NUmber and serial number  GEMINI Dual 4535 679 00891 G097, G119, 101-103, 105-107, 109-117, 119-127, 131-144, 146-164, 1025, 2003506, 2003507, 1Z9Z591, 2Z9Z591, 3Z9Z591, 4Z9Z591, GY9Z591, HY9Z591, JY9Z591  GEMINI 16 Power 4535 679 58961 1002, 1004-1008, 1010-1015, 1017-1028, 1030-1034, 1035R, 1036A, 1037-1046, 101R, 1023a, G098, MNM4411  GEMINI GXL (6, 10, 16, and 16 Mobile) 4535 679 75691, 4535 679 81871, 4535 679 76581, 4535 679 71891 4001, 4003-4040, 4042-4089, 4091-4123, 4125-4127, 4129-4137, 4139-4143, 7011, 4097A, 4147a  GEMINI TF 16 Slice (16, 64, 64 Mobile and 16 Base) 4535 679 83931, 4535 674 47551, 4535 679 94741, 4535 674 41711 7001, 7003-7006, 7008, 7009, 7013-7017, 7022, 7024, 7025, 7027, 7028"
    }
  ]
}