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Recall Observatory FDA recall evidence

Device product

Ventana HE 600 System, automated slide preparer, for use in laboratories.

Z-1374-2022

June 01, 2022

Class II

Product summary

Firm
Ventana Medical Systems Inc
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

    reason.no_named_rule · v1.0.0

    There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire