BEUDAMED
    FDA Enforcement Class II Ongoing

    MIM software; System, Image Processing, Radiological

    Recall: Z-1267-2025 · Reported March 12, 2025

    Enforcement

    Recall Number
    Z-1267-2025
    Event ID
    96314
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MIM Software Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 12, 2025
    Initiation Date
    February 19, 2025
    Classification Date
    March 4, 2025
    Address
    25800 Science Park Dr Ste 180, Cleveland, OH, 44122-7311, United States

    Description

    MIM software; System, Image Processing, Radiological

    Reason

    In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result.

    Code Info

    Software versions: 1. MIM Anyware 1.1, UDI/DI Not Applicable 2. MIM 7.2.0, UDI/DI 00850009343192; 3. MIM 7.2.1, UDI/DI 00850009343192; 4. MIM 7.2.2, UDI/DI 00850009343192; 5. MIM 7.2.3, UDI/DI 00850009343192; 6. MIM 7.2.4, UDI/DI 00850009343192; 7. MIM 7.2.5, UDI/DI 00850009343192; 8. MIM 7.2.6, UDI/DI 00850009343192

    Distribution

    Worldwide distribution - United States Nationwide and the countries of Australia, Belgium, Bolivia, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom, Finland, Hong Kong.

    Quantity

    352 units