{"recall":{"id":"fda-device-98998","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Ventana Medical Systems, Inc. recalls navify Digital Pathology (on-prem) v2","firm":"Ventana Medical Systems, Inc.","date":"2026-04-20","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In 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. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.","code":"navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ Software version Numbers: 2.5.0, 2.5.0.1, 2.5.0.2, and 2.5.1","quantity":"190","number":"Z-2913-2026","classification":"Class II"}],"reason":"Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"190","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98998","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"488d64c6769ff08f","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98998","record":[{"status":"Ongoing","city":"Tucson","state":"AZ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98998","recalling_firm":"Ventana Medical Systems, Inc.","address_1":"1910 E Innovation Park Dr","address_2":"","postal_code":"85755-1962","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-2913-2026","product_description":"navify Digital Pathology (on-prem) v2.5, Material Number 10092343001    navify Digital Pathology (Cloud) v2.5. Material Number 09453733001    UDI-DI Code: 761333602095AQ      In 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.  Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.","product_quantity":"190","reason_for_recall":"Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window","recall_initiation_date":"20260420","center_classification_date":"20260807","report_date":"20260819","code_info":"navify Digital Pathology (on-prem) v2.5, Material Number 10092343001  navify Digital Pathology (Cloud) v2.5. Material Number 09453733001  UDI-DI Code: 761333602095AQ  Software version Numbers: 2.5.0, 2.5.0.1, 2.5.0.2, and 2.5.1","more_code_info":""}]}}