Lower risk Medical device recall · FDA · Published April 20, 2026

Ventana navify Digital Pathology v2.5 Software Image Discrepancy Recall

Ventana recalls navify Digital Pathology v2.5 software versions due to image/metadata discrepancies in Viewer window. Affected users should contact Ventana for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2913-2026Medical device Ventana ›

Lower-risk recall

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

✎ GovInfoNow plain-language explainer

Ventana is recalling specific versions of their navify Digital Pathology software (v2.5) because users report image and metadata mismatches with the Viewer window. This could lead to incorrect medical imaging results if not fixed. Read more at govinfonow.com/recall/460045-ventana-navify-digital-pathology-v2-5-software-image-discrepancy-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/460045-ventana-navify-digital-pathology-v2-5-software-image-discrepancy-recall · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2913-2026

Cite this page

“Ventana navify Digital Pathology v2.5 Software Image Discrepancy Recall.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/460045-ventana-navify-digital-pathology-v2-5-software-image-discrepancy-recall. Based on FDA recall #Z-2913-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2913-2026%22&limit=1).

The FDA announced on April 20, 2026, that Ventana Medical Systems, Inc. is recalling navify Digital Pathology software versions 2.5 due to image and metadata discrepancies in the Viewer window. The recall affects 190 units distributed worldwide.

How to tell if you have it

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001
navify Digital Pathology (Cloud) v2.5, Material Number 09453733001
UDI-DI Code: 761333602095AQ
Software versions 2.5.0, 2.5.0.1, 2.5.0.2, and 2.5.1

The hazard

According to the FDA, complaints were received regarding an image or metadata discrepancy with the Viewer window in the Image Management System.

Context

GovInfoNow's records show Ventana Medical Systems, Inc. has issued seven other recalls since December 19, 2017. Recent brand recalls include a June 27, 2024 recall for false positive results risk and a November 18, 2022 recall for light staining causing false-negative results. Other recent recalls of similar products include GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall (July 31, 2026), GE Healthcare Centricity PACS Software Recall (July 31, 2026), and GE Healthcare Enterprise Archive V8 Software Recall (July 31, 2026).

How to tell if you have this one

Check for software versions v2.5.0, v2.5.0.1, v2.5.0.2, or v2.5.1 on the Ventana navify Digital Pathology system. The UDI-DI code 761333602095AQ identifies the affected units.

Brand
Ventana
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify the exact software version on your system to confirm if it is affected (v2.5.0, v2.5.0.1, v2.5.0.2, or v2.5.1).
Contact Ventana
Reach out to Ventana Medical Systems for assistance with the recall and potential fixes.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 33 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 4 months after the firm started it.

Apr 20, 2026Firm started the recall
Aug 7, 2026FDA classified it Class II
Aug 19, 2026Published in FDA’s Enforcement Report
Aug 27, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall is for software discrepancies that could affect medical imaging accuracy, but it does not pose an immediate risk of injury or death. Ventana considers this a low-risk issue.

Similar recalls

Latest medical device recalls

Keep exploring

More Ventana recalls

Link to this recall

<a href="https://govinfonow.com/recall/460045-ventana-navify-digital-pathology-v2-5-software-image-discrepancy-recall">Ventana navify Digital Pathology v2.5 Software Image Discrepancy Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2913-2026 (April 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2913-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.