{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "164663",
      "product_res_number": "Z-2184-2018",
      "event_date_initiated": "2017-12-04",
      "event_date_created": "2018-06-13",
      "recall_status": "Open, Classified",
      "res_event_number": "80137",
      "product_code": "JOY",
      "k_numbers": [
        "K033840",
        "K092868"
      ],
      "product_description": "CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60\n\nProduct Usage:\nThe devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells",
      "code_info": "Versions 6.0.1 or 6.0.2",
      "firm_fei_number": "3003630693",
      "recalling_firm": "Cellavision AB",
      "address_1": "19a forskningsbyn ideon scheelevagen",
      "city": "Lund",
      "country": "Sweden",
      "reason_for_recall": "A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.",
      "root_cause_description": "Software design",
      "action": "CellaVision sent an Urgent Medical Device Recall letter dated December 4, 2017.  The letter identified affected product, problem and the actions to be taken.   Customers are requested to determine if they are affected or not. If affected they are requested to contact their local distributor for installing a patch.\nCustomers are asked to confirm receipt of the notice by signing and dating the\nattached Acknowledgement Form and emailing a copy to their local distributor.\nFor technical questions contact CelleVision (service@cellavision.se)",
      "product_quantity": "Instruments: 224 Software: 99 (US)",
      "distribution_pattern": "US Nationwide in the states of FL, IL, NY, and NC",
      "openfda": {
        "k_number": [
          "K003301",
          "K092868",
          "K980375",
          "K982301",
          "K171315",
          "K080595",
          "K201301",
          "K982786",
          "K071398",
          "K030192",
          "K033840",
          "K040591",
          "K970824",
          "K960776",
          "K220013",
          "K062755",
          "K960774",
          "K973050",
          "K061392",
          "K052577",
          "K971470",
          "K050840",
          "K102778",
          "K964689",
          "K061602",
          "K243144",
          "K001420",
          "K221309",
          "K200595",
          "K772140",
          "K925670",
          "K182062",
          "K772139",
          "K984188",
          "K092116"
        ],
        "device_name": "Device, Automated Cell-Locating",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5260",
        "device_class": "2",
        "registration_number": [
          "3010960914",
          "9615060",
          "3003909093",
          "3018182832",
          "3009711478",
          "3010421384",
          "3020704087",
          "9613959",
          "3009834076",
          "3003630693"
        ],
        "fei_number": [
          "3009505338",
          "3003909093",
          "3018182832",
          "3009711478",
          "3010421384",
          "3002808301",
          "3020704087",
          "3010960914",
          "3009834076",
          "3003630693"
        ]
      }
    }
  ]
}