navify Digital Pathology — Class II medical device recall Z-2913-2026
Ongoing recall by Ventana Medical Systems, Inc., reported 2026-08-19, distributed nationwide. Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewe
| Recall number | Z-2913-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventana Medical Systems, Inc., Tucson, AZ, United States |
| Recall initiated | 2026-04-20 |
| Classified | 2026-08-07 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, BR, CH, CL, CO, CZ, DE, DO, EC, ES, FR, GB, HK, IE, IN, IT, JO, MX, NL, PE, PT, RO, TR |
| Quantity | 190 |
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 for recall
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2913-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.