BEUDAMED
    FDA Adverse Event Summary report: N

    INFINIA

    MDR report key: 3422151 · Received September 17, 2013

    Report

    Report Number
    3422151
    Date Received
    September 17, 2013
    Date of Event
    July 15, 2013
    Report Date
    September 17, 2013
    Manufacturer
    GE HEALTHCARE LLC
    Product Code
    LNH
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RECALL OF INFINI NUCLEAR MEDICINE SYSTEM. WE ONLY HAVE THE OPTIMA MR450W 1.5TR MRI FOR INTELIRAD PACS. OUR IT OPERATIONS DIRECTOR WITH THE RADIOLOGY GROUP CONFIRMED THAT WE DO NOT USE THIS VERSION EFFECTING THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469007 INFINIA SCANNER, WHOLE BODY, NUCLEAR LNH GE HEALTHCARE LLC OPTIMA MR450W 1.5T MRI *
    469008 * * --- GE HEALTHCARE LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *