BEUDAMED
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    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code IYE·April 15, 2014

    RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.

    FDA Recall
    Terminated ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code MUJ·March 11, 2019

    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

    FDA Recall
    Terminated ·Brainlab AG Kapellenstr. 12 Feldkirchen Germany·Product code LLZ·September 21, 2015

    ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code IYE·February 16, 2015

    iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code MUJ·November 19, 2014

    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code IYE·July 16, 2013

    iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code MUJ·November 19, 2014

    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code IYE·June 24, 2014

    VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany Intended to be an intraoperative image guided localization system to enable minimally invasive surgery. Indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy.

    FDA Recall
    Terminated ·Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany·Product code MUJ·November 12, 2007

    BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number 20620 - Radiosurgery 3.5 and Catalog number 20630 - Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals.

    FDA Recall
    Terminated ·Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany·Product code MUJ·August 12, 2009

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Recall
    Terminated ·Brainlab AG Kapellenstr. 12 Feldkirchen Germany·Product code MUJ·November 5, 2015

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Recall
    Terminated ·Brainlab AG Kapellenstr. 12 Feldkirchen Germany·Product code MUJ·November 5, 2015

    Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code HAW·November 18, 2013

    Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 17, 2018

    Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 18, 2017

    Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

    FDA Recall
    Terminated ·Brainlab AG Olof-Palme-Strasse 9 Munich Germany·Product code OLO·October 27, 2016

    Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·October 30, 2019

    Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

    FDA Recall
    Terminated ·Brainlab AG Olof-Palme-Strasse 9 Munich Germany·Product code HAW·November 16, 2017

    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·March 4, 2015

    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.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 25, 2015