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MEDICAL DEVICE RECALLMODERATE

navify Digital Pathology Software

Ventana recalls navify Digital Pathology v2.5 over image/metadata discrepancy in the Viewer window.

What to do

If you use navify Digital Pathology (on-prem) v2.5 or (Cloud) v2.5, contact Ventana Medical Systems for instructions on updating or correcting the software to resolve the image/metadata discrepancy.

Recalled
Listed
Updated
Recall No.
Z-2913-2026
Agency
FDA
Firm
Ventana Medical Systems, Inc.
Recall ID
98998
Status
ONGOING

Why it was recalled

Ventana Medical Systems is recalling navify Digital Pathology (on-prem) v2.5 and navify Digital Pathology (Cloud) v2.5 due to complaints of image/metadata discrepancy with the Viewer window in the Image Management System. The software is a component of the Roche Digital Pathology Dx device used for Whole Slide Imaging.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification