BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YSIO X.PREE GEN2

    MDR report key: 24296935 · Received February 9, 2026

    Report

    Report Number
    3004977335-2026-00019
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 27, 2026
    Report Date
    May 5, 2026
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    KPR
    UDI-DI
    004056869962214
    PMA / PMN Number
    K250738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: SIEMENS HEALTHINEERS COMPLETED A DETAILED INVESTIGATION OF THE REPORTED PROBLEM. FOR INSTALLATION, THE TUBE STAND IS LIFTED TO THE CEILING USING DEFINED LASHING POINTS (EYE BOLTS). DURING THE LIFTING PROCESS PERFORMED BY TWO SERVICE PROVIDER EMPLOYEES, ONE OF THE LASHING POINTS WAS TORN OUT OF ITS FASTENING. THE INVESTIGATION IDENTIFIED THAT THE AFFECTED LASHING POINT WAS NOT SCREWED IN DEEP ENOUGH. DUE TO THE CUSTOMER-SPECIFIC CEILING CONSTRUCTION VARIANT PREPARED BY THE CUSTOMER THEMSELVES, THE USED EYE BOLT COULD NOT BE SCREWED ADEQUATELY INTO THE SLIDING NUT. THE REASON FOR THIS WAS THAT THE INDIVIDUAL PROFILE OF THE RAIL WAS HIGHER THAN IN OTHER CONSTRUCTION VARIANTS. THE EXECUTING SERVICE PROVIDER HAS TO ENSURE A SUFFICIENT NUMBER OF ENGAGED THREADS AND THUS THE NECESSARY LOAD-BEARING CAPACITY. UNDER LOAD, THE EXISTING THREADS SHEARED OFF, LEADING TO THE FALL OF THE TUBE STAND. THE RELEVANT INSTALLATION DOCUMENTATION WAS REVISED, AND AN ADDITIONAL STEP WAS INTRODUCED REQUIRING MEASUREMENT OF THE RAIL DEPTH AND THE HEIGHT OF THE UPWARD-STANDING PROFILE PRIOR TO INSTALLATION TO DETERMINE THE CORRECT EYE BOLT LENGTH AND TO ENSURE SUFFICIENT THREAD ENGAGEMENT. IN ADDITION, ALL INSTALLATION COMPANIES AND THEIR PERSONNEL WERE INFORMED AND SENSITIZED ABOUT THE INCIDENT AND THE RESULTING ADJUSTMENTS THROUGH THE FACTORY INSTALLATION DEPARTMENT TO ENSURE LONG-TERM SAFETY OF ALL PARTIES INVOLVED AND PREVENT REOCCURRENCE. THE CUSTOMER RECEIVED A NEW TUBE STAND. THE COMPLAINT HAS BEEN CLOSED.

    Additional Manufacturer Narrative · 0

    H3, H6: THE DAMAGED COMPONENTS WERE REPLACED BY NEW ONES. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL REPORTABLE INFORMATION IS AVAILABLE UPON THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SIEMENS HEALTHINEERS WAS NOTIFIED OF A PROBLEM INVOLVING THE YSIO X.PREE GEN2 SYSTEM. DURING THE INSTALLATION OF THE 3D TUBE STAND TRANSVERSE CARRIAGE THE COMPONENT, INCLUDING THE TUBE STAND, FELL FROM THE CEILING TO THE FLOOR. ONE OF THE CHAIN HOISTS THAT WAS USED FOR LIFTING THE COMPONENT UP TO THE CEILING WAS ATTACHED TO A LIFTING EYE BOLT, WHICH DETACHED FROM ITS NUT. THIS CAUSED THE WHOLE ASSEMBLY TO FALL DOWN. THERE WAS NO REPORT OF INJURY ASSOCIATED WITH THIS EVENT. IN A WORST-CASE SCENARIO, A CRITICAL INJURY OR DEATH COULD RESULT IF THE EVENT WERE TO REOCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516918 YSIO X.PREE GEN2 SYSTEM, X-RAY, STATIONARY KPR SIEMENS HEALTHINEERS AG 11574001 004056869962214

    Patients

    Seq Age Sex Outcome Treatment
    1