FDA-Device2022-07-20Class II
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Ventana Medical Systems Inc
Hazard
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Sold states
US: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: Canada, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Argentina, Australia, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates (UAE), Vietnam
Affected count
763 instruments
Manufactured in
1910 E Innovation Park Dr, Oro Valley, AZ, United States
Products
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1374-2022Don't want to check this manually?
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