FDA Device recall Z-2280-2023
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides by Hamamatsu, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2280-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-06 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hamamatsu |
| Distribution | NY |
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
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.
Identifiers
| code_info | UDI-DI: 010458238901065911220 S/N: 90121100033 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2280-2023%22
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