Z-2913-2026Class II

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5...

Name: Z-2913-2026 navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5...
Creator: Ventana Medical Systems, Inc.
Published: 2026-04-20
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2026-04-20 / Open, Classified / root cause: software

FDA source

Ventana Medical Systems, Inc. began a recall of navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code... on 2026-04-20. FDA classified it as Class II and gives the reason as "Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2913-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-20
Posted: 2026-08-07
Recalling firm: Ventana Medical Systems Inc
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.
Product code: PSY Whole Slide Imaging System
Reason for recall: Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Root cause tag: software
FDA root cause: Software design
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
Quantity in commerce: 190
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2913-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2913-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07

Product code PSY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)