BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECELL GO

    MDR report key: 24583086 · Received March 12, 2026

    Report

    Report Number
    24583086
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 9, 2026
    Manufacturer
    AVITA MEDICAL AMERICAS, LLC
    Product Code
    QCZ
    UDI-DI
    00851707004286
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RECELL MACHINE FAULTED ERROR CODE W02 AT 5 MINUTES REMAINING IN THE MACHINE CYCLE. VENDOR REP PRESENT FOR DURATION, ESCALATED CONCERNS TO AVITA ENGINEER TO TROUBLESHOOT, BUT WAS UNSUCCESSFUL IN OBTAINING A SUFFICIENT AMOUNT OF PATIENT'S SKIN FROM MACHINE. AN ADDITIONAL GRAFT HAD TO BE OBTAINED. THE EMERGENCY EJECT FEATURE RECOMMENDED TO ENGINEER DURING PHONE CALL WHILE EXPERIENCING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639739 RECELL GO MECHANICAL AND ENZYMATIC AUTOLOGOUS SKIN PROCESSOR FOR CELL SUSPENSION, WITH APP QCZ AVITA MEDICAL AMERICAS, LLC AVRL0103 103859 00851707004286

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other