medical Class II Updated 2023-08-09

Hamamatsu Corporation recalls NanoZoomer S360MD Slide scanner system-automated system for

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: NY
Lot/Code Info: UDI-DI: 010458238901065911220 S/N: 90121100033
View official government recall

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