{
  "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": "220432",
      "product_res_number": "Z-2913-2026",
      "event_date_initiated": "2026-04-20",
      "event_date_posted": "2026-08-07",
      "recall_status": "Open, Classified",
      "res_event_number": "98998",
      "product_code": "PSY",
      "k_numbers": [
        "K232879",
        "K242783"
      ],
      "product_description": "navify Digital Pathology (on-prem) v2.5, Material Number 10092343001\n\nnavify Digital Pathology (Cloud) v2.5. Material Number 09453733001\n\nUDI-DI Code: 761333602095AQ\n\n\nIn the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes.\nRoche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.",
      "code_info": "navify Digital Pathology (on-prem) v2.5, Material Number 10092343001\n\nnavify Digital Pathology (Cloud) v2.5. Material Number 09453733001\n\nUDI-DI Code: 761333602095AQ\n\nSoftware version Numbers:\n2.5.0, 2.5.0.1,\n2.5.0.2, and\n2.5.1",
      "firm_fei_number": "1000125183",
      "recalling_firm": "Ventana Medical Systems, Inc.",
      "address_1": "1910 E Innovation Park Dr",
      "city": "Tucson",
      "state": "AZ",
      "postal_code": "85755-1962",
      "additional_info_contact": "Natalie Catton\n317-478-1703",
      "reason_for_recall": "Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window",
      "root_cause_description": "Software design",
      "action": "On 05/01/2026, the firm sent via UPS Ground an \"URGENT MEDICAL DEVICE CORRECTION\" Letter informing customers that Roche eceived two complaints outside of the U.S. concerning the navify Digital Pathology (nDP) image management system regarding an issue where images may be mismatched or associated with incorrect specimen and slide labels within a given case. The discrepancy occurs exclusively within a subset of individual cases in which a specific nomenclature is used for specimen names and the case contains multiple specimens.\n\nCustomers are instructed to:\n\" Until navify Digital Pathology software version 2.5.2 goes live on May 8th at 6:30 PM PDT (9:30 PM EDT), users should zoom into or select slide images and cross-reference specimen/block/slide labels with the correct, synchronized information in the top Case Bar, Thumbnail Panel, or Slide Info Panel in the Viewer window before proceeding with clinical analysis.\n\" Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients.\n\" Complete all sections of the enclosed recall response form (TP-02782) and fax it to 1-833-237-1015 or email it to roche4435@sedgwick.com.\n\" Distribute this UMDC within your facility and network to ensure relevant personnel are aware of the issue.\n\" File this Urgent Medical Device Correction (UMDC) for future reference.\n\nFor Questions - contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336",
      "product_quantity": "190",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, WI, and WV. The countries of Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Romania, Spain, and Switzerland, Argentina, Bosnia & Herzegovina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Jordan, Mexico, Myanmar, Peru, Turkey, United Kingdom, Australia, Bahrain, Colombia, Hong Kong, Portugal and India.",
      "openfda": {
        "k_number": [
          "K253606",
          "K213883",
          "K260964",
          "K242848",
          "K192259",
          "K232202",
          "K241871",
          "K251952",
          "K203364",
          "K243871",
          "K233204",
          "K253554",
          "K232208",
          "K190332",
          "K232879",
          "DEN160056",
          "K232833",
          "K233027",
          "K203845",
          "K172174",
          "K242783",
          "K241717",
          "K230839"
        ],
        "registration_number": [
          "2028492",
          "3000126629",
          "3025774973",
          "9614683",
          "3012563754",
          "3017125738",
          "3008491142",
          "1000181154",
          "3003584784",
          "3005060446",
          "9613188",
          "3006791373"
        ],
        "fei_number": [
          "3004455125",
          "3000126629",
          "3025774973",
          "3012563754",
          "3003794634",
          "3017125738",
          "3008491142",
          "1000181154",
          "3003584784",
          "3005060446",
          "3006791373",
          "1000125183"
        ],
        "device_name": "Whole Slide Imaging System",
        "medical_specialty_description": "Pathology",
        "regulation_number": "864.3700",
        "device_class": "2"
      }
    }
  ]
}