Ventana Medical Systems, Inc.: navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In th

Hazard

Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

Details from the source

Reason for recall: Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window 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, Domin Quantity: 190 Lot/code info: 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

UPC codes

10092343001, 09453733001

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.