# FDA recall Z-2280-2023

> **Hamamatsu Corporation** · Class II · device recall initiated 2023-06-06.

## 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.

## Distribution

NY

## Key facts

- **Recall number:** Z-2280-2023
- **Recalling firm:** Hamamatsu Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-06
- **Report date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2280-2023

## Citation

> AI Analytics. FDA recall Z-2280-2023. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2280-2023. Source: US FDA. Licensed CC0.

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