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Ventana Medical Systems Inc Recall 90363

Description: Ventana HE 600 System

Ventana Medical Systems Inc Recall 90363 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1374-2022
Event ID90363
Event DescriptionVentana HE 600 System
Product TypeDevices
DistributionUS: 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
Quantity763 instruments
Recall ReasonThere is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Device Classification20220720
Device Code InfoAll Lots; UDI/DI: 04015630976010
Center Classification Date20220712
Recall Initiation Date20220601
Recalling FirmVentana Medical Systems Inc
Initial Notification Letter
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