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Aperio AT2 DX Scanner
LEICA BIOSYSTEMS IMAGING, INC · Model 23AT2DX · UDI-DI 00815477020259
PSY
Prescription
1
510(k) clearances
8
Adverse events
2
Recalls
13
Facilities
Description
Aperio AT2 DX Scanner for Primary Diagnosis. Includes installation and one day of training. One year warranty. Must be used in conjunction with Aperio DX Viewing Station for Primary Diagnosis.
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.
