navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Num
FDA device recall Z-2913-2026 · posted 2026-08-07 · Open, Classified
Recall details
- Recalling firm
- Ventana Medical Systems, Inc.
- Reason for recall
- Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
- Action taken
- On 05/01/2026, the firm sent via UPS Ground an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that Roche eceived two complaints outside of the U.S. concerning the navify Digital Pathology (nDP) image management system regarding an issue where images may be mismatched or associated with incorrect specimen and slide labels within a given case. The discrepancy occurs exclusively within a subset of individual cases in which a specific nomenclature is used for specimen names and the case contains multiple specimens. Customers are instructed to: " Until navify Digital Pathology software version 2.5.2 goes live on May 8th at 6:30 PM PDT (9:30 PM EDT), users should zoom into or select slide images and cross-reference specimen/block/slide labels with the correct, synchronized information in the top Case Bar, Thumbnail Panel, or Slide Info Panel in the Viewer window before proceeding with clinical analysis. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " Complete all sections of the enclosed recall response form (TP-02782) and fax it to 1-833-237-1015 or email it to roche4435@sedgwick.com. " Distribute this UMDC within your facility and network to ensure relevant personnel are aware of the issue. " File this Urgent Medical Device Correction (UMDC) for future reference. For Questions - contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- PSY
- Quantity affected
- 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, a
- Date initiated
- 2026-04-20
- Date posted
- 2026-08-07
- Location
- Tucson, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
| Roche Digital Pathology Dx (VENTANA DP 200) (K232879) | Ventana Medical Systems, Inc. | 2024-06-14 |