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    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

    FDA Recall
    Open, Classified ·Fujifilm Medical Systems U.S.A., Inc.·Product code LLZ·May 22, 2020

    FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code KPR·April 11, 2024

    FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code KPR·September 15, 2025

    FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code KPR·January 9, 2026

    Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·February 11, 2025