BEUDAMED
    FDA Enforcement Class I Terminated

    Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

    Recall: Z-1061-2015 · Reported February 25, 2015

    Enforcement

    Recall Number
    Z-1061-2015
    Event ID
    70238
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alltech Medical Systems America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 25, 2015
    Initiation Date
    January 9, 2015
    Classification Date
    February 18, 2015
    Termination Date
    September 15, 2015
    Address
    28900 Fountain Pkwy, Solon, OH, 44139-4383, United States

    Description

    Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

    Reason

    The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

    Code Info

    Serial numbers: D-ESP-1001 and D-ESP-1003

    Distribution

    US Distribution in the state of Maryland.

    Quantity

    2 units