BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 20748405 · Received November 21, 2024

    Report

    Report Number
    8020021-2024-00530
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Report Date
    November 21, 2024
    Manufacturer
    GE HEALTHCARE AUSTRIA GMBH & CO OG
    Product Code
    ITX
    UDI-DI
    00840682105026
    PMA / PMN Number
    K180374
    Removal / Correction Number
    Z-0865-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS KRETZ - TIEFENBACH 15 AUSTRIA ZIPF OBEROSTERREICH, 4871. GE HEALTHCARE REPORTED A FIELD MODIFICATION FOR THIS IC9-RS DOUBLE IMAGE MALFUNCTION PER 21 CFR 806 ON 29-DEC-2023. THE US-FDA RECALL NUMBER IS Z-0865-2024. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND REQUESTING THE CUSTOMER TO PERFORM AN INSPECTION TEST TO DETERMINE IF THE PROBE IS MALFUNCTIONING. GE HEALTHCARE HAS DETERMINED THE CAUSE OF THE MALFUNCTIONING PROBE TO BE A PROBE COMPONENT. TO CORRECT THIS ISSUE, GE HEALTHCARE WILL REPLACE THE PROBE UPON COMPLETION OF THE FIELD ACTION AT THIS SITE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. IT WAS CONCLUDED THE IC9-RS DIAGNOSTIC ULTRASOUND PROBE WAS IDENTIFIED AS HAVING A COMPONENT MALFUNCTION DESCRIBED IN US-FDA RECALL NO. Z-0865-2024 INITIATED BY GE HEALTHCARE ON 29-DEC-2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138952 NA DIAGNOSTIC ULTRASOUND TRANSDUCER ITX GE HEALTHCARE AUSTRIA GMBH & CO OG IC9-RS 00840682105026

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female