FDA Device recall Z-1374-2022
Ventana HE 600 System, automated slide preparer, for use in laboratories
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Ventana HE 600 System, automated slide preparer, for use in laboratories by Ventana Medical Systems, citing there is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1374-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-01 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ventana Medical Systems |
| Distribution | 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 |
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
Identifiers
| code_info | All Lots; UDI/DI: 04015630976010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1374-2022%22
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