{
  "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": "2026-09-12",
    "results": {
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  "results": [
    {
      "cfres_id": "193571",
      "product_res_number": "Z-1248-2022",
      "event_date_initiated": "2022-04-13",
      "event_date_created": "2022-06-08",
      "recall_status": "Open, Classified",
      "res_event_number": "90146",
      "product_code": "MEC",
      "product_description": "Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc.\nModel: CM320 WU",
      "code_info": "UDI-DI: 07340153700185\nSerial Numbers:\nW50034570\nWAA070170\nWAA070618\nWAA081312",
      "firm_fei_number": "3013876692",
      "recalling_firm": "Getinge Usa Sales Inc",
      "address_1": "1 Geoffrey Way",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-2035",
      "reason_for_recall": "Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection",
      "root_cause_description": "Process control",
      "action": "Getinge issued to U.S. consignees Medical Device Correction Letter dated April 13, 2022 via FedEx delivery. Letter states reason for recall, health risk and action to take:\nPlease examine your inventory immediately to determine if you have any Getinge\nCM320-series Washer Disinfectors with the REF number/serial numbers listed on\npage 1.\n\nYou can continue to use Getinge CM320-series Washer Disinfectors until the\ncorrective action is performed; there are no precautionary actions necessary.\n2. Please complete and sign the attached MEDICAL DEVICE CORRECTION -\nRESPONSE FORM (page 5) to acknowledge that you have received this notification.\n\nA Getinge service technician will review the Installation Checklist and verify that each of the steps were performed to ensure continual safe operation of your cart washer(s). This review and verification will be performed. Questions contact your Getinge representative or Technical Support please call (888) 943-8872 (options 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m.\n(Eastern Time Zone). Technical Support can also be reached via email at\ntechsupportIC.us@getinge.com.",
      "product_quantity": "4 units",
      "distribution_pattern": "US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.",
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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"
        ]
      }
    }
  ]
}