FDA Device recall Z-2262-2020
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) labor…
- FDA Device
- Class II
- completed
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) labor… by Ventana Medical Systems, citing the firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathol….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2262-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-10-04 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ventana Medical Systems |
| Distribution | US |
Product
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
Reason
The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2262-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.