Reported Aug 19, 2026 · Ongoing · Updated Sep 16, 2026

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material…

Ventana Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ventana Medical Systems, Inc. · 1910 E Innovation Park Dr · Tucson, AZ · 85755-1962

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5
Material Number 09453733001 UDI-DI Code761333602095AQ 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

Lot codes and dates: navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5
Material Number 09453733001 UDI-DI Code761333602095AQ
Software version Numbers
2.5.0
2.5.0.1
2.5.0.2
and 2.5.1
Amount recalled: 190

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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