{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Cleveland",
      "address_1": "595 Miner Rd",
      "reason_for_recall": "The block used to connect the patient pallet to the couch may be assembled incorrectly.  A screw may be misaligned in the patient pallet.",
      "address_2": "",
      "product_quantity": "32 units",
      "code_info": "Serial Numbers:  900004  900005  900006  900007  900008  900009  900010  900011  900012  900013  900014  900015  900016  900017  900018  900019  900020  900021  900022  900023  900024  900025  900026  900027  900028  900029  900030  900031  900032  900033  900034  900035",
      "center_classification_date": "20180719",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of CA, GA, LA, MD, MI, NY, OH, TN, TX, VT, Washington DC & WI  Internationally - Canada, Mexico, Belgium, France, Israel, Luxembourg, Netherlands, Singapore, Spain & Switzerland",
      "state": "OH",
      "product_description": "Ingenuity Digital PET/CT System, Model 882446 with the following UDI's:   (01)00884838059559(21)900004  (01)00884838059559(21)900005  (01)00884838059559(21)900006  (01)00884838059559(21)900007  (01)00884838059559(21)900008  (01)00884838059559(21)900009  (01)00884838059559(21)900010  (01)00884838059559(21)900011  (01)00884838059559(21)900012  (01)00884838059559(21)900013  (01)00884838059559(21)900014  (01)00884838059559(21)900015  (01)00884838059559(21)900016  (01)00884838059559(21)900017  (01)00884838059559(21)900018  (01)00884838059559(21)900019  (01)00884838059559(21)900020  (01)00884838059559(21)900021  (01)00884838059559(21)900022  (01)00884838059559(21)900023  (01)00884838059559(21)900024  (01)00884838059559(21)900025  (01)00884838059559(21)900026  (01)00884838059559(21)900027  (01)00884838059559(21)900028  (01)00884838059559(21)900029  (01)00884838059559(21)900030  (01)00884838059559(21)900031  (01)00884838059559(21)900032  (01)00884838059559(21)900033  (01)00884838059559(21)900034  (01)00884838059559(21)900035    Product Usage:  The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.",
      "report_date": "20180725",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Philips Medical Systems (Cleveland) Inc",
      "recall_number": "Z-2496-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80400",
      "termination_date": "20200410",
      "more_code_info": "",
      "recall_initiation_date": "20180521",
      "postal_code": "44143-2131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}