BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERGO IMAGING SYSTEM

    MDR report key: 23732795 · Received December 5, 2025

    Report

    Report Number
    2031050-2025-00002
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 5, 2025
    Manufacturer
    DIGIRAD DIAGNOSTIC IMAGING (DBA CATALYST MEDTECH)
    Product Code
    KPS
    UDI-DI
    00850816007003
    PMA / PMN Number
    K123408
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED A REPORT THAT ON 11/05/2025, THE EXTENSION ARM ASSEMBLY (P/N: 118083, REV E) ON AN ERGO IMAGING SYSTEM (SN: (B)(6) EXPERIENCED A SUDDEN STRUCTURAL FAILURE DURING ROUTINE SETUP FOR A RENAL SCAN. THE NUCLEAR MEDICINE TECHNOLOGIST WAS ROTATING THE ARM WHEN THE CARBON STEEL ARM TUBING FRACTURED, CAUSING THE DETECTOR HEAD TO FALL ONTO THE GANTRY BASE. NO PATIENT WAS PRESENT AND NO INJURY OCCURRED. THE SYSTEM WAS REMOVED FROM SERVICE AND REPAIRED ON 11/07/2025. NO FURTHER ISSUES WERE REPORTED. THE FAILED ARM ASSEMBLY WAS RETURNED FOR ENGINEERING EVALUATION. ANALYSIS CONFIRMED THAT THE INSTALLED ARM WAS A LEGACY PART NUMBER P/N: 118083 REVISION E COMPONENT ORIGINALLY SUPPLIED AS PART OF A GANTRY SUBASSEMBLY MANUFACTURED IN 2020. THIS LEGACY DESIGN PRE-DATED THE WELDING AND STRUCTURAL IMPROVEMENTS IMPLEMENTED UNDER ENGINEERING CHANGE ORDER ECO C10950 (P/N: 118083 REVISION F, RELEASED 05/03/2022) AND IS NO LONGER USED IN CURRENT PRODUCTION. REVIEW OF MANUFACTURING AND DEVICE HISTORY RECORDS CONFIRMED THAT THE DEVICE WAS BUILT ACCORDING TO SPECIFICATION AT THE TIME OF MANUFACTURE AND PASSED ALL REQUIRED FINAL TESTING. NO EVIDENCE OF MISUSE OR ABNORMAL LOADING WAS IDENTIFIED. FAILURE ANALYSIS DETERMINED THE ROOT CAUSE TO BE MATERIAL/DESIGN LIMITATIONS OF THE LEGACY ARM ASSEMBLY (P/N 118083 REV E). CURRENT PRODUCTION UTILIZES UPDATED ARM DESIGNS (REVISIONS F AND G) THAT INCORPORATE REINFORCED WELD GEOMETRY DEVELOPED AS PART OF A PRIOR CORRECTIVE AND PREVENTIVE ACTION AND HAVE NOT SHOWN SIMILAR FAILURES. COMPLAINT, SERVICE HISTORY, AND DEVICE HISTORY RECORD REVIEWS IDENTIFIED NO TREND OF STRUCTURAL FAILURES IN CURRENT ARM REVISIONS. A FIELD ASSESSMENT WAS COMPLETED TO IDENTIFY OTHER POTENTIALLY AFFECTED UNITS. SIXTEEN (16) FIELD UNITS WERE EVALUATED; EIGHT (8) UNITS CONTAINED THE LEGACY ARM ASSEMBLY AND WERE SCHEDULED FOR REPLACEMENT, AND SEVEN (7) UNITS RECEIVED PROACTIVE REPLACEMENT WITH THE CURRENT DESIGN. TECHNICAL SERVICE BULLETIN FOR INTERNAL COMMUNICATION TO FIELD SERVICE ENGINEERS WAS ISSUED TO GOVERN INSPECTION AND REPLACEMENT ACTIVITIES. A CORRECTIVE AND PREVENTIVE ACTION RECORD WAS INITIATED TO ADDRESS RECURRENCE CONTROL AND CORRECTIVE ACTIONS. NO DESIGN OR MANUFACTURING DEFICIENCIES WERE IDENTIFIED IN THE CURRENT ARM ASSEMBLIES, AND THE MALFUNCTION IS ISOLATED TO THE OBSOLETE COMPONENT INSTALLED AT THE TIME OF SYSTEM BUILD. THE DEVICE HAS BEEN REPAIRED AND RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DURING SETUP FOR A RENAL SCAN, THE EXTENSION ARM OF THE ERGO IMAGING SYSTEM (SERIAL NUMBER: (B)(6) EXPERIENCED A SUDDEN STRUCTURAL FAILURE. AS THE OPERATOR ROTATED THE ARM TO POSITION THE DETECTOR HEAD UPWARD, THE EXTENSION ARM (P/N: 118083 REV E) FRACTURED AT THE WELDED JOINT. THE DETECTOR HEAD DROPPED ONTO THE BASE OF THE GANTRY. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT, AND NO INJURIES OCCURRED. THE SYSTEM BECAME NON-OPERATIONAL AND WAS REMOVED FROM USE. THE FIELD SERVICE ENGINEER REPLACED THE FAILED EXTENSION ARM WITH THE CURRENT PRODUCTION DESIGN (P/N: 118083 REV G) ON 11/07/2025, AND THE SYSTEM RETURNED TO NORMAL FUNCTION. THE FAILED PART WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990192 ERGO IMAGING SYSTEM ERGO LITHIUM DOMESTIC IMAGING SYSTEM KPS DIGIRAD DIAGNOSTIC IMAGING (DBA CATALYST MEDTECH) 126930 REV J 00850816007003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown