Hamamatsu Corporation: Medical Device Recall in 2023 - (Recall #: Z-2280-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 6, 2023

Date Posted: August 9, 2023

Recall Number: Z-2280-2023

Event ID: 92627

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.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

UDI-DI: 010458238901065911220 S/N: 90121100033

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated