{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "121170",
      "product_res_number": "Z-0018-2014",
      "event_date_initiated": "2013-07-30",
      "event_date_posted": "2013-10-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-05-11",
      "res_event_number": "66000",
      "product_code": "MEC",
      "product_description": "Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196\n\nProduct Usage:  The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.",
      "code_info": "Model # 46-4,  Serial # range SEV0521184-SEV0838137",
      "firm_fei_number": "3000231474",
      "recalling_firm": "Getinge Disinfection",
      "address_1": "Ljungadalsgatan 11 11 ljungadalsgatan",
      "city": "Vaxjo",
      "country": "Sweden",
      "reason_for_recall": "Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Getinge USA, Inc. sent a Device Correction Notices letter dated July 26, 2013 to all affected customers via US Postal Certified Mail within the U.S. and Canada.  The letter identified the affected product, problem and actions to be taken.  The letter indicate that all customers will be contacted by a Getinge representative for guidance if any machine within the serial number range of affected product is within their possession.  If you should have any questions or concerns regarding this field correction, please call 1-800-475-9040, press \"1\" and enter extension 5036.",
      "product_quantity": "143 units (142 domestically & 1 unit internationally)",
      "distribution_pattern": "USA Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and internationally in Canada.",
      "openfda": {
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        "fei_number": [
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        ],
        "device_name": "Disinfector, Medical Devices",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.6992",
        "device_class": "2",
        "k_number": [
          "K911120",
          "K081094"
        ]
      }
    }
  ]
}