Ventana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
Ventana Medical Systems is recalling navify Digital Pathology software versions 2.5 due to reported discrepancies between images and metadata in the viewer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a software discrepancy in image metadata, which is a functional defect rather than a direct physical injury risk, fitting the Moderate category for software-related issues without reported injuries.
Plain-English summary
Ventana Medical Systems, Inc. is recalling 190 units of navify Digital Pathology software, including both on-prem and cloud versions, version 2.5. The software is a component of the Roche Digital Pathology Dx device, which is cleared by the FDA for whole slide imaging purposes.
The recall was initiated due to complaints regarding the Image Management System, specifically noting discrepancies between images and metadata within the Viewer window. The affected software versions include 2.5.0, 2.5.0.1, 2.5.0.2, and 2.5.1.
The product was distributed nationwide in the United States and in numerous countries worldwide, including Austria, Belgium, Brazil, Germany, India, and the United Kingdom. Users of the affected software should contact Ventana Medical Systems for further instructions on how to resolve the issue.
The recalled product
- 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)…
- Manufacturer
- Ventana Medical Systems, Inc.
- Category
- Medical Device — Software
- Affected units
- 190
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- navify Digital Pathology (on-prem) v2.5
- 2.5.0.1
- 2.5.0.2
- and 2.5.1
Distribution
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