Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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.

FDA Recall Z-2913-2026 · Posted 2026-08-07

Recalling FirmVentana Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodePSY
Date Initiated2026-04-20
Product Quantity190

Reason for Recall

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

Firm Action

On 05/01/2026, the firm sent via UPS Ground an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that Roche eceived two complaints outside of the U.S. concerning the navify Digital Pathology (nDP) image management system regarding an issue where images may be mismatched or associated with incorrect specimen and slide labels within a given case. The discrepancy occurs exclusively within a subset of individual cases in which a specific nomenclature is used for specimen names and the case contains multiple specimens. Customers are instructed to: " Until navify Digital Pathology software version 2.5.2 goes live on May 8th at 6:30 PM PDT (9:30 PM EDT), users should zoom into or select slide images and cross-reference specimen/block/slide labels with the correct, synchronized information in the top Case Bar, Thumbnail Panel, or Slide Info Panel in the Viewer window before proceeding with clinical analysis. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " Complete all sections of the enclosed recall response form (TP-02782) and fax it to 1-833-237-1015 or email it to [email protected]. " Distribute this UMDC within your facility and network to ensure relevant personnel are aware of the issue. " File this Urgent Medical Device Correction (UMDC) for future reference. For Questions - contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K242783Roche Digital Pathology DxVentana Medical Systems, Inc. · 2024-12-17K232879Roche Digital Pathology Dx (VENTANA DP 200)Ventana Medical Systems, Inc. · 2024-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑