BEUDAMED
    FDA Enforcement Class II Terminated

    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

    Recall: Z-0917-2017 · Reported January 4, 2017

    Enforcement

    Recall Number
    Z-0917-2017
    Event ID
    75833
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shimadzu Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 4, 2017
    Initiation Date
    November 20, 2016
    Classification Date
    December 23, 2016
    Termination Date
    December 11, 2017
    Address
    20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States

    Description

    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

    Reason

    Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.

    Code Info

    Serial No. 41C351641002 41C351643001 41C351641003 41C351641001 41C351646001 41C351646002 41C351647001 41C35164A001 41C35164B001 41C35164C001 41C351651001 41C351651002 41C351653003 41C351653002 41C351653004 41C351653005 41C351654002 41C351655001 41C351655002 41C351655003 41C351656001 41C351659001 41C35165A001 41C35165A002 41C35165A003 41C35165B001 41C35165B002 41C351661001 41C351661002 41C351662001 41C351663001 41C351663002 41C351664001 41C351664002 41C351664004 41C351664005 41C351665001 41C351665003 41C351665002

    Distribution

    US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA

    Quantity

    39 units