FDA recall, , Moderate risk
Roche Navify Digital Pathology Software
Navify Digital Pathology software has an image/metadata discrepancy with the Viewer window.
Summary by Recall Canary from the FDA notice
What happened
Ventana Medical Systems, Inc., of Tucson, Arizona, recalled navify Digital Pathology (on-prem) v2.5, Material Number 10092343001, and navify Digital Pathology (Cloud) v2.5, Material Number 09453733001, due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window.
The software is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. The recall began April 20, 2026, and was classified by the FDA on August 7, 2026. Distribution was worldwide, including nationwide in the U.S. and in countries such as Austria, Brazil, France, Germany, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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)
- UDI-DI
- 10092343001
- 09453733001
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, PR, South Carolina, South Dakota, Tennessee, Texas, Utah, Wisconsin, and West Virginia. 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.
- Company
- Ventana Medical Systems, Inc.Tucson, Arizona
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98998
- Recall number
- Z-2913-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
