NanoZoomer S360MD Slide scanner system-automated system for creating — Class II medical device recall Z-2280-2023
Ongoing recall by Hamamatsu Corporation, reported 2023-08-09, distributed in NY. If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide imag
| Recall number | Z-2280-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamamatsu Corporation, Bridgewater, NJ, United States |
| Recall initiated | 2023-06-06 |
| Classified | 2023-07-31 |
| Reported by FDA | 2023-08-09 |
| Distributed | NY |
| Quantity | 1 units |
| Model numbers | C13220-01MD |
Product
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD
Reason for recall
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.
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-2280-2023. 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.