Home / Recalls / Ventana Medical Systems, Inc. / Z-2913-2026

Z-2913-2026 Class II Ongoing

Recalled by Ventana Medical Systems, Inc. — Tucson, AZ

FDA device recall Z-2913-2026 was initiated by Ventana Medical Systems, Inc. on April 20, 2026 and is designated Class II. Reason for recall: Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window The recall status is ongoing. Affected quantity: 190.

Recall Details

Product Type
Devices
Report Date
August 19, 2026
Initiation Date
April 20, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
190

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

Distribution Pattern

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, 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.

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

Other recalls by Ventana Medical Systems, Inc.

  • Z-2644-2024 Class II — Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD (June 27, 2024)
  • Z-0907-2023 Class II — VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 0770937 (November 18, 2022)
  • Z-1374-2022 Class II — Ventana HE 600 System, automated slide preparer, for use in laboratories. (June 1, 2022)
  • Z-0894-2022 Class II — BenchMark ULTRA and DISCOVERY ULTRA Instruments (January 20, 2022)
  • Z-2262-2020 Class II — Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s (October 4, 2019)
  • Z-3005-2018 Class I — ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemis (August 2, 2018)
  • Z-2997-2018 Class I — ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 (August 2, 2018)
  • Z-3016-2018 Class I — ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Imm (August 2, 2018)
  • Z-2999-2018 Class I — ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 (August 2, 2018)
  • Z-3003-2018 Class I — ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760- (August 2, 2018)

FDA data resources