Device product
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Z-1374-2022
Product summary
- Event
- Event 90363
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 763 instruments
- Official record key
device-enforcement:Z-1374-2022
Official wording
Reason: There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Code information: All Lots; UDI/DI: 04015630976010
Distribution pattern: 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
Derived failure modes
-
Unknown
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire