BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 20857308 · Received December 5, 2024

    Report

    Report Number
    8020021-2024-00669
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Report Date
    December 5, 2024
    Manufacturer
    GE HEALTHCARE AUSTRIA GMBH & CO OG
    Product Code
    ITX
    PMA / PMN Number
    K230346
    Removal / Correction Number
    Z-0865-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    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 HAS REPLACED THIS MALFUNCTIONING PROBE.

    Description of Event or Problem · 0

    AN INSPECTION TEST WAS PERFORMED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE ON 29-DEC-2023 (US-FDA RECALL NO. Z-0865-2024), AND 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. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376327 NA DIAGNOSTIC ULTRASOUND TRANSDUCER ITX GE HEALTHCARE AUSTRIA GMBH & CO OG IC9-RS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown