Z-2280-2023Class II

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

Name: Z-2280-2023 NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides...
Creator: Hamamatsu Corporation
Published: 2023-06-06
License: https://open.fda.gov/license/

Hamamatsu Corp. / initiated 2023-06-06 / Open, Classified / root cause: software

FDA source

Hamamatsu Corporation began a recall of NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality... on 2023-06-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2280-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-06
Posted: 2023-08-01
Recalling firm: Hamamatsu Corp.
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
Product code: PSY Whole Slide Imaging System
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.
Root cause tag: software
FDA root cause: Software design
Action: Hamamatsu Corporation issued Urgent: Medical Device Correction Letter via Email on 6/6/23. Letter states reason for recall, health risk and action to take: The risk of recurrence will be fully eliminated by conducting the NZAcquire software update on the user PCs either by a Field Service Engineer being on site or via a remote control. As a precautionary measure, there are two kinds of risk mitigations in place to reduce the potential serious risk. 1. There is a clear note in the NZAcquireMD Reference manual regarding the barcode information. 2. There is a warning in the system manual that the intended use of WSI generated out of the system is designed to provide information as an aid for a diagnosis among other information. 2. There is a warning in the system manual that the intended use of WSI generated out of the system is designed to provide information as an aid for a diagnosis among other information available. In other words, medical decisions should not be made exclusively based on the data from the device. Provide the contact information of the appropriate person with whom we can arrange a time to complete this service. Please provide the following information for the contact person by emailing us at: [email protected] The affected users will perform one temporary measure to the software settings
Quantity in commerce: 1 unit
Distribution: NY
Product codes and lots: UDI-DI: 010458238901065911220 S/N: 90121100033

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2280-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2280-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31

Product code PSY

K213883Class IINanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. / cleared 2022-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)