Ventana Medical Systems, Inc. recalls navify Digital Pathology (on-prem) v2.5

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

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 roche4435@sedgwick.com. " 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

• FDA enforcement recordOfficial FDA database entry for Z-2913-2026
• FDA 510(k) clearance · K232879The device's official FDA premarket clearance record
• FDA 510(k) clearance · K242783The device's official FDA premarket clearance record
• FDA device classification · PSYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.3700The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ventana Medical Systems, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.