BEUDAMED
    FDA Recall Open, Classified

    Synapse PACS - Version 7.1.000US

    Recall: Z-1269-2024 · Initiated January 10, 2024

    Recall

    Recall Number
    Z-1269-2024
    Event Number
    94090
    Firm
    FUJIFILM Healthcare Americas Corporation
    FEI Number
    1000513161
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    January 10, 2024
    Posted
    March 7, 2024
    Address
    81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160

    Description

    Synapse PACS - Version 7.1.000US

    Reason

    Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

    Action

    URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers January 26, 2024. In an abundance of caution, FUJIFILM is recommending that customer/end users take one of the following actions until the correction is applied: 1. To not perform measurements on Secondary Capture Images that are displayed together with Breast Tomo Images. 2. Ensure Secondary Capture Image has valid pixel spacing values using the DICOM Header Tool. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken. Please contact our field action coordinator, Kotei Aoki, via phone at 765-246-2931 or email at [email protected], if you have any further questions regarding this field action. Please keep a copy of this letter with your instructions for use.

    Distribution

    Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.

    Quantity

    3 Units (3 US)