DeviceSignal · Recall classified
Ventana Medical Systems, Inc.
FDA classified a device recall on 2026-08-07 · Class II · Z-2913-2026
EventRecall classified
Effective2026-08-07
ClassificationClass II
On 2026-08-07 the FDA classified a device recall from Ventana Medical Systems, Inc. as Class II. Product: navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital…. Recall Z-2913-2026. The firm initiated it on 2026-04-20. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2913-2026
- Classification
- Class II
- Classified on
- 2026-08-07
- Initiated on
- 2026-04-20
- Firm
- Ventana Medical Systems, Inc.
- Reason
- Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
- 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2913-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
c22ce673ea270e3828f2e5ced46a8cc480ea0c1b3537d30220d067cc1bf200cb- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)