BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLIMATOR, AUTOMATIC, RADIOGRAPHIC

    MDR report key: 20929805 · Received December 13, 2024

    Report

    Report Number
    1000513161-2024-00039
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    October 23, 2024
    Report Date
    January 14, 2025
    Manufacturer
    SIEMENS HEALTHINEERS
    Product Code
    IZW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMP # (B)(4).

    Additional Manufacturer Narrative · 0

    COMP # (B)(4). SUPPLEMENTAL S1 IS SUBMITTED TO UPDATE THE PRODUCT NAME.

    Description of Event or Problem · 0

    ON DECEMBER 2ND, 2024, THE FUJIFILM AMERICAS HEALTHCARE CORPORATION RECEIVED A MEDWATCH MW5162227 REPORT REGARDING A POTENTIAL PERFORMANCE ISSUE WITH THE FUJI DEVO SUITE II X-RAY SYSTEM. IT WAS REPORTED THAT A "CUTOFF" IS OBSERVED WHEN THE COLLIMATOR BLADES ARE FULLY OPENED ALONG THE ANODE-TO-CATHODE AXIS OF THE X-RAY TUBE. THE CUTOFF IS SEEN ON THE ANODE SIDE, AND THE AMOUNT OF CUTOFF VARIES DEPENDING ON THE SOURCE-TO-IMAGE DISTANCE (SID). THE AMOUNT OF CUTOFF EXCEEDS THE FDA'S REQUIREMENT OF 2% OF SID. THERE IS NO PATIENT HARM OR INJURY REPORTED AS PER MEDWATCH MW5162227 REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2412987 COLLIMATOR, AUTOMATIC, RADIOGRAPHIC COLLIMATOR, AUTOMATIC, RADIOGRAPHIC IZW SIEMENS HEALTHINEERS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown