Official recall notice

FDA DeviceClass IINotable

navify Digital Pathology v2.5 Recall (Aug 2026)

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.

Recall date
2026-08-19
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

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

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