BEUDAMED
    FDA Enforcement Class II Terminated

    Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)

    Recall: Z-2124-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2124-2016
    Event ID
    74391
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Esaote S.p.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    June 6, 2016
    Classification Date
    July 5, 2016
    Termination Date
    May 30, 2017
    Address
    Via Di Caciolle,15, N/A, Firenze, N/A, N/A, Italy

    Description

    Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)

    Reason

    The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. Additionally, a weight limit is added to the patient seat for weight-bearing examinations.

    Code Info

    Item No., Unit Description and Serial No.s: 101002000, UNIT, G-SCAN BRIO, 05202; 101002000, UNIT, G-SCAN BRIO, 05203; 101002000, UNIT, G-SCAN BRIO 2.1A; 05205; 101002000, UNIT, G-SCAN BRIO 2.1A, 05207; 101002000 UNIT, G-SCAN BRIO 2.1A, 05208; 101002000 UNIT, G-SCAN BRIO 2.1A, 05209; 101002000 UNIT, G-SCAN BRIO 2.1A, 05210; 101002000 UNIT, G-SCAN BRIO 2.1A, 05211; 101002000 UNIT, G-SCAN BRIO 2.1A, 05305; 101002000 UNIT, G-SCAN BRIO 2.1A, 05308

    Distribution

    Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.

    Quantity

    11 USA; 29 OUS