Class II U.S. Food and Drug Administration

Ventana Medical Systems, Inc. navify Digital Pathology v2.5 recall: Due to complaints received for the Image Management System regarding

Recall published 2 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2913-2026
Published
August 19, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Ventana Medical Systems, Inc.
Product type
Medical devices
Units affected
190
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
761333602095

Products covered by this recall

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.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 761333602095

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Ventana Medical Systems, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Ventana Medical Systems, Inc. — 1910 E Innovation Park Dr, Tucson, AZ, 85755-1962

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Ventana Medical Systems, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 761333602095. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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