Recall archive / FDA device enforcement
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZ... — FDA record Z-2280-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Hamamatsu Corporation
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2280-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 010458238901065911220 S/N: 90121100033 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
NY
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 9, 2023
- Recall initiation date
- Jun 6, 2023
- Center classification date
- Jul 31, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.