Z-2280-2023 Class II Ongoing

Recalled by Hamamatsu Corporation — Bridgewater, NJ

Recall Details

Product Type
Devices
Report Date
August 9, 2023
Initiation Date
June 6, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

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

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 Pattern

NY

Code Information

UDI-DI: 010458238901065911220 S/N: 90121100033