Ventana Medical Systems Inc Recall 90363
Description: Ventana HE 600 System, automated slide preparer, for use in laboratories.
Ventana Medical Systems Inc Recall 90363 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1374-2022 |
| Event ID | 90363 |
| Event Description | Ventana HE 600 System, automated slide preparer, for use in laboratories. |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 763 instruments |
| Recall Reason | There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire |
| Device Classification | 20220720 |
| Device Code Info | All Lots; UDI/DI: 04015630976010 |
| Center Classification Date | 20220712 |
| Recall Initiation Date | 20220601 |
| Recalling Firm | Ventana Medical Systems Inc |
| Initial Notification | Letter |
| Similar To |