Recall Z-1172-2021 ยท PGY Display, Diagnostic Radiology
Barco N.V.
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
| Date | Jan 22, 2021 |
| Status | Terminated |
| Reason | A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests. |
| Root cause | Process change control |
| Action | On January 22, 2021 the firm notified the importer in the USA, Barco Inc. |
| Quantity | 1 unit |
| Distribution | WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170837 | Nio Color 3MP (MDNC-3421) Barco N.V., Apr 5, 2017 |