Model Number: 06917259001 UDI: 04015630976010 — Class II medical device recall Z-2262-2020
Completed recall by Ventana Medical Systems Inc, reported 2020-06-17, distributed nationwide. The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 6
| Recall number | Z-2262-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventana Medical Systems Inc, Oro Valley, AZ, United States |
| Recall initiated | 2019-10-04 |
| Classified | 2020-06-05 |
| Reported by FDA | 2020-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CR, DE, DK, EC, ES, FI, FR, GB, HK, HR, IE, IT, JP, KR, KW, LB, MY, NO, PE, PL, SA, SE, SI, SK, SV, TH, TW, VN |
| Quantity | 461 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04015630976010 |
| Model numbers | 06917259001 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2262-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.