Class II — Barco N.V.
| Recalling firm | BARCO NV |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests. |
| Product | Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY |
| Quantity | 1 unit |
| Distribution | WI. |
| Initiated | 2021-01-22 |
| Classified | 2021-03-04 |
| Terminated | 2022-11-18 |
| Recall number | Z-1172-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Barco N.V. (Z-1172-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87288/
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