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Class IIOngoing

Ventana Medical Systems, Inc. recalls navify Digital Pathology (on-prem) v2

Recall date · record updated Aug 19, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

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.

Company
Ventana Medical Systems, Inc.
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).
Who’s 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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98998…

Products

  1. 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.

    Codes/lots: 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 2.5.1Quantity: 190Recall no. Z-2913-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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