BEUDAMED
    FDA Enforcement Class II Terminated

    BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.

    Recall: Z-0282-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0282-2016
    Event ID
    71248
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    May 8, 2015
    Classification Date
    November 17, 2015
    Termination Date
    February 28, 2017
    Address
    Kapellenstrasse 12, N/A, Feldkirchen, N/A, N/A, Germany

    Description

    BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.

    Reason

    Instances of data sets not being accurately registered to the patient anatomy were observed.

    Code Info

    Model/catalogue numbers: 19060 AIR ICT S&T W/O G.C. NEUROLOGICA BODYTOM; 19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL. Potentially affected is the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices (Cranial / ENT version 2.1 and Spine & Trauma 3D versions 2.0 and 2.1)

    Distribution

    Distributed in the US and Australia.

    Quantity

    12 systems total (10 in U.S., 2 in Australia)