Ventana Medical Systems Inc: Medical Device Recall in 2022 - (Recall #: Z-1374-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 1, 2022

Date Posted: July 20, 2022

Recall Number: Z-1374-2022

Event ID: 90363

Reason for Recall:

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

Status: Ongoing

Product Quantity: 763 instruments

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

Voluntary or Mandated:

Voluntary: Firm initiated