FDAClass IIAugust 9, 2023

NanoZoomer S360MD Slide scanner system-automated system recall

NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates…

Why was NanoZoomer S360MD Slide scanner system-automated system 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 010458238901065911220 S/N: 90121100033

Product
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates…
Recalling firm
Hamamatsu Corporation
Quantity
1 unit
Distribution
NY
Recall date
August 9, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls