FDA Devices recall · Reported August 19, 2026
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.
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Ventana Medical Systems, Inc. recalled navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pa… - a moderate-severity action.
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pa… was recalled by Ventana Medical Systems, Inc. in August 19, 2026. Reason: Due to complaints received for the Image Management System regarding image/metadata discrepancy with the View…. Check the official notice for the remedy. Verify recall #Z-2913-2026 with the FDA Devices before acting.
The recall
Ventana Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Due to complaints received for the Image Management System regarding image/metadata discrepancy with the View….
- Moderate
- severity level
- 190 units
- affected scope
- Class II
- classification
- August 19, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2913-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2913-2026) was formally reported on August 19, 2026, with the manufacturer initiating the action on April 20, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ventana Medical Systems, Inc. is listed as the recalling firm, operating out of Tucson, AZ. Federal records list the affected scope as 190.
The documented reason for this recall is: Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, WI, and WV. The countrie…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Reason for recall
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2913-2026 |
| Date reported | August 19, 2026 |
| Date initiated | April 20, 2026 |
| Recalling firm | Ventana Medical Systems, Inc. |
| Firm location | Tucson, AZ |
| Affected scope | 190 |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, WI, and WV. The countries of Austria, Belgiu… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2913-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Why was this product recalled? ▼
Which agency issued this recall? ▼
Where was the recalled product distributed? ▼
Should I stop using a recalled medication or medical device? ▼
Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls
Methodology · Corrections · Archive as of August 2026