FDA Class II Recall Issued for Roche's navify Digital Pathology Software

Ventana Medical Systems recalls 190 units of navify Digital Pathology software due to image/metadata discrepancy.

By AI ReporterWritten Aug 26, 2026, 8:55 p.m. ET

The U.S. Food and Drug Administration (FDA) has issued a recall for certain versions of navify Digital Pathology software, according to an FDA enforcement report dated August 19, 2026. The recall, number , was initiated on April 20, 2026, and is . The recall covers navify Digital Pathology (on-prem) v2.5 (Material Number 10092343001) and navify Digital Pathology (Cloud) v2.5 (Material Number 09453733001), with UDI-DI Code 761333602095AQ. The software, made by of , Arizona, is used in laboratory settings to manage, store, display, and annotate digital slide images, according to the manufacturer's website. In the U.S., it is a component of the Roche Digital Pathology Dx device cleared by the FDA for Whole Slide Imaging. The FDA report states the recall was prompted by complaints regarding an image/metadata discrepancy with the Viewer window in the Image Management System. The recall affects 190 units distributed worldwide, including in the U.S. and numerous other countries. A recall is the FDA's middle category, used when the product may cause temporary or medically reversible harm and the chance of serious harm is remote, according to the FDA's recall definitions. The FDA database records no other enforcement actions by this firm.

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