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

FDA device recall Z-2280-2023 · posted 2023-08-01 · Open, Classified

Recall details

Recalling firm

Hamamatsu Corporation

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.

Action taken

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: nanozoomerqanotifications@hamamatsu.com The affected users will perform one temporary measure to the software settings

Root cause

Software design

Status

Open, Classified

Product code

PSY

Quantity affected

1 unit

Distribution

NY

Date initiated

2023-06-06

Date posted

2023-08-01

Location

Bridgewater, NJ

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