Recall archive / FDA device enforcement
Ventana HE 600 System, automated slide preparer, for use in laboratories. — FDA record Z-1374-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Ventana HE 600 System, automated slide preparer, for use in laboratories.
- Reason
- There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
- Classification
- Class II
- Recalling firm
- Ventana Medical Systems Inc
- Quantity
- 763 instruments
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1374-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All Lots; UDI/DI: 04015630976010 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Jersey
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
Dates in the source
- Report date
- Jul 20, 2022
- Recall initiation date
- Jun 1, 2022
- Center classification date
- Jul 12, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.