BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-2280-2023 · Initiated June 6, 2023

    Recall

    Recall Number
    Z-2280-2023
    Event Number
    92627
    Firm
    Hamamatsu Corporation
    FEI Number
    1000121818
    Product Code
    PSY
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 6, 2023
    Posted
    August 1, 2023
    Address
    360 Foothill Rd, Bridgewater, NJ, 08807-2920

    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

    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

    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

    Distribution

    NY

    Quantity

    1 unit