Hamamatsu Corporation recalls NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoo…

Recall date

June 6, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2280-2023

FDA classification

Class II

Brand / firm

Hamamatsu Corporation

Sold / distributed

NY

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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