BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ICONO BIPLANE

    MDR report key: 23728116 · Received December 5, 2025

    Report

    Report Number
    3004977335-2025-00140
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 24, 2025
    Report Date
    February 17, 2026
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    04056869063317
    PMA / PMN Number
    K241572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 G07002 - SUPPORT ARM. THE INVESTIGATION OF THE REPORTED ISSUE SHOWED THAT THE SWIVEL JOINT OF THE EXTENSION ARM OF THE UPPER RADIATION PROTECTION SHIELD WAS DAMAGED, CAUSING THE SUPPORT ARM TO BEND TOWARD THE FLOOR. ACCORDING TO THE SYSTEM EXPERT, THE REPORTED COLLISION BETWEEN THE C-ARM AND THE SUPPORT ARM LIKELY OCCURRED DURING A USER-CONTROLLED SYSTEM MOVEMENT. SUCH COLLISION CAN OCCUR IF THE USER DOES NOT CHECK FOR POSSIBLE OBSTACLES BEFORE RELEASING SYSTEM MOVEMENTS. THE OPERATOR MANUAL PROVIDES ADEQUATE INSTRUCTIONS REGARDING SYSTEM MOVEMENT AND HOW OPERATORS CAN AVOID COLLISIONS, SEE CHAPTER 7.1 ¿SAFETY INSTRUCTIONS ¿ SYSTEM MOVEMENTS. RISK OF COLLISION, RISK OF INJURY TO PATIENT OR OPERATOR, RISK OF DAMAGE TO UNIT PARTS.¿ IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE THAT UNIT MOVEMENTS ARE RELEASED ONLY IF IT IS CERTAIN THAT NEITHER THE OPERATOR, THE PATIENT, THIRD PARTIES NOR OTHER PIECES OF EQUIPMENT CAN BE ENDANGERED BY THESE MOVEMENTS. ALWAYS PAY ATTENTION TO POSSIBLE COLLISIONS DURING UNIT MOVEMENTS. MAKE SURE THAT NOBODY IS STANDING INSIDE THE DANGER AREA. REMOVE ANY OBJECTS OR ACCESSORIES FROM COLLISION AREA, E.G. INJECTOR OR INFUSION STAND. THE DAMAGED SUPPORT ARM WAS REPLACED BY SIEMENS LOCAL SERVICE. THE OCCURRENCE RATE OF THE IDENTIFIED CAUSE HAS BEEN CHECKED, AND NO ERROR ACCUMULATION HAS BEEN IDENTIFIED. THE OCCURRENCE RATE IS BELOW THE DEFINED THRESHOLD.

    Additional Manufacturer Narrative · 0

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED ON THE ARTIS ICONO BIPLANE UNIT. THE ARM OF RADIATION PROTECTION SHIELD WAS REPORTED TO BE DAMAGED. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING; THEREFORE THE EVENT IS REPORTED IN DOUBT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2783801 ARTIS ICONO BIPLANE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 11327600 04056869063317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown