Ventana Medical Systems, Inc. recalls navify Digital Pathology

Recalling company

Ventana Medical Systems, Inc.

Product

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.

Reason

Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Apr 20, 2026

Reported

Aug 19, 2026

Distribution

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.

Status

Ongoing

Quantity

190

Lot / codes

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

Company location

Tucson, AZ

Recall type

Voluntary: Firm initiated

Recall number

Z-2913-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2913-2026 in the FDA Enforcement Report. Also see FDA recall press releases.