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U.S. Department of Health and Human Services

Class 2 Device Recall navify Digital Pathology software

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 Class 2 Device Recall navify Digital Pathology softwaresee related information
Date Initiated by FirmApril 20, 2026
Date PostedAugust 07, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2913-2026
Recall Event ID 98998
510(K)NumberK232879 K242783 
Product Classification Whole slide imaging system - Product Code PSY
Productnavify 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.
Code Information navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ Software version Numbers: 2.5.0, 2.5.0.1, 2.5.0.2, and 2.5.1
FEI Number 1000125183
Recalling Firm/
Manufacturer		 Ventana Medical Systems, Inc.
1910 E Innovation Park Dr
Tucson AZ 85755-1962
For Additional Information ContactNatalie Catton
317-478-1703
Manufacturer Reason
for Recall		Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
FDA Determined
Cause 2		Software design
ActionOn 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
Quantity in Commerce190
DistributionWorldwide - 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, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Romania, Spain, and Switzerland, Argentina, Bosnia & Herzegovina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Jordan, Mexico, Myanmar, Peru, Turkey, United Kingdom, Australia, Bahrain, Colombia, Hong Kong, Portugal and India.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PSY
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