Ventana navify Digital Pathology v2.5 recalled for image mismatch
Ventana Medical Systems is recalling navify Digital Pathology software, version 2.5, used with the Roche Digital Pathology Dx slide imaging system. Customers reported that images did not match their information (metadata) in the viewer window. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- If your lab uses this software, contact Roche or Ventana for guidance on the fix.
- This notice does not list a specific remedy, so confirm the next steps with the manufacturer before continuing use.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- All ages (18 years to 100 years)
Details
- Units affected
- 190
- Illnesses reported
- None reported
- Manufactured in
- 1910 E Innovation Park Dr, Tucson, AZ, United States
- Classification
- Class II
- Recall number
- Z-2913-2026
In the FDA's words
- 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. Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window 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 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, 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. Affected quantity: 190
- Hazard
- Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window