BARCO
Barco NV · Model MDPC-8127 · UDI-DI 05415334044289
PSY
Prescription
10
510(k) clearances
8
Adverse events
2
Recalls
12
Facilities
Description
MDPC-8127
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-20 | Ventana Medical Systems, Inc. | Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window |
| 2023-06-06 | Hamamatsu Corporation | If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.