BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOSTAR SPICA 1.5T MRI

    MDR report key: 4504008 · Received February 6, 2015

    Report

    Report Number
    3009885280-2015-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Report Date
    February 6, 2015
    Manufacturer
    ALLTECH MEDICAL SYSTEMS AMERICA INC.
    Product Code
    LNH
    PMA / PMN Number
    K113511
    Removal / Correction Number
    3009885280-01/12/15-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACTED FDA RECALL COORDINATOR AND INITIATED A VOLUNTARY RECALL.

    Description of Event or Problem · 1

    AN MRI SAFETY FEATURE WHICH LOWERS THE MAGNETIC FIELD IN AN EMERGENCY SITUATION MAY NOT WORK CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85900 ECHOSTAR SPICA 1.5T MRI MAGNETIC RESONANCE IMAGING LNH ALLTECH MEDICAL SYSTEMS AMERICA INC. 2011

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S