Z-1374-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2022
- Initiation Date
- June 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 763 instruments
Product Description
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Reason for Recall
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
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
Code Information
All Lots; UDI/DI: 04015630976010