{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Cleveland",
      "address_1": "595 Miner Rd",
      "reason_for_recall": "The following issues have been found in MX 16-slice systems with software version 1.1.4.21426:    1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient\u0019s images before pasting, a previous patient\u0019s images may be present in the clipboard and be copied onto the film of the current patient.      2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started.    3. If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function",
      "address_2": "",
      "product_quantity": "80 units",
      "code_info": "Model No. 728132; S/N:   EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER110004, EP16ER110005, EP16ER110006, EP16ER110007, EP16ER110008, EP16ER110009, EP16ER110010, EP16ER110011, EP16ER110012, EP16ER110013, EP16ER110014, EP16ER110015, EP16ER110016, EP16ER110017, EP16ER110018, EP16ER110019, EP16ER110020, EP16ER110021, EP16ER110022, EP16ER110023, EP16ER110024, EP16ER120001, EP16ER120002, EP16ER120003, EP16ER120004, EP16ER120005, EP16ER120006, EP16ER120007, EP16ER120008, EP16ER120010, EP16ER120012, EP16ER120015, EP16ER120016, EP16ER120017, EP16ER120018, EP16ER130001, EP16ER130002, EP16ER130005, EP16ER130006, EP16ER130007, EP16ER130008, EP16ER130009, EP16ER130010, EP16ER130011, EP16ER130012, EP16ER130013, EP16ER130014, EP16ER130015, EP16ER130016, EP16ER130018, EP16ER130025, EP16ER130026, EP16ER130029, EP16ER130033,  EP16ER130034, EP16EB150009 & EP16EB150014.    Model No.728135; S/N:   EP16E120009, EP16E120011, EP16E120013, EP16ER130003, EP16ER130004, EP16ER130017, EP16ER130019, EP16ER130020, EP16ER130021, EP16ER130022, EP16ER130023, EP16ER130024, EP16ER130027, EP16ER130028, EP16ER130030, EP16ER130031 & EP16ER130032.",
      "center_classification_date": "20160805",
      "distribution_pattern": "Products were sold in the following states: AL, AR, CA, FL, GA, IL, IN, MS, NC, ND, NJ, NV, NY, OH, PA, SC, TN & VA.    Products were also shipped to the following countries: Albania, ALGERIA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Cape Verde, Chile, China, Colombia, Congo, Democratic, Costa Rica, Cyprus, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, India, INDONESIA, Ireland, Italy, Japan, Jordan, Latvia, Lebanon, Libyan Arab Jamahiri, Lithuania, Malawi, Mali, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Nigeria, Oman, Palestine, Paraguay, Philippines, Poland, Romania, Russia, Senegal, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Kingdom, Venezuela, Viet Nam & Zambia.",
      "state": "OH",
      "product_description": "MX 16-slice SKD whole body computed tomography X-ray system.  Imaging diagnostic tool.",
      "report_date": "20160817",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Philips Medical Systems (Cleveland) Inc",
      "recall_number": "Z-2347-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74402",
      "termination_date": "20180702",
      "more_code_info": "",
      "recall_initiation_date": "20160420",
      "postal_code": "44143-2131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}