BEUDAMED
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    Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·May 13, 2020

    RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·April 1, 2015

    Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·June 10, 2013

    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code IYE·August 12, 2019

    Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 6, 2013

    Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·February 6, 2009

    Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acuity (used with BrainLab M3 MLC); Product Number 83 (used with Product Number 53); Product Number 48 (used with Product Number 53); Product Number 77 (used with Product Number 53); Product is distributed by Varian Medical Systems, 911 Hansen Way, Palo Alto, CA 94304

    FDA Recall
    Terminated ·Varian Medical Systems Inc·Product code IWB·November 23, 2005

    Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.

    FDA Enforcement
    Class II ·Terminated·Elekta Inc·December 20, 2017

    XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·October 3, 2010

    BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC, model 41600-5, -5 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany. The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation.

    FDA Recall
    Terminated ·Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany·Product code IYE·March 19, 2009

    BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany. The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation.

    FDA Recall
    Terminated ·Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany·Product code IYE·March 19, 2009

    XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·May 19, 2010

    RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·March 28, 2018

    ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Concord, CA; Intended to deliver x-ray radiation for therapeutic treatment of cancer. ARTISTE with 160 MLC, Part No.8139789, ONCOR AG with 160 MLC, Part No.5863472 ONCOR Impression Plus with 160 MLC, Part No.5857912, ONCOR Expression with 160 MLC, Part No.7360204, ONCOR Expression with 160 MLC, Part No.7360717, PRIMUS HI with HPD, Part No. 4504200, MEVATRON M2 / PRIMUS Mid-Energy / HPD, Part No.1940035, MEVATRON 6323-2 / HPD, Part No.19244500, MEVATRON K2 / HPD, Part No.1940753, MEVATRON PRIMART / HPD, Part No.5500371, MEVATRON 77 / HPD, Part No.5659503, MEVATRON M 7400 / 7440 (MEX) / HPD, Part No.5672977, MEVATRON M 6700 (MX) / HPD, Part No.5693908, MEVATRON M 6730 / HPD, Part No.5694005, MEVATRON M 7140 / HPD, Part No.5694104, MEVATRON M 7400 / HPD, Part No.5694153, MEVATRON M 7445 / HPD (MEX), Part No.5694203, MEVATRON K 7467 / HPD, Part No.5694252, MEVATRON K 7767 / HPD, Part No.5694302, MEVATRON K 8067 / HPD, Part No.5694401, MEVATRON M 6300 (MX) / HPD, Part No.8317000, MEVATRON M 6730/6740 (MEX) / HPD, Part No.8319758, MEVATRON MD (MD, MDX) / HPD, Part No.8319808, MEVATRON KD / HPD, Part No.8319857, MEVATRON MDX / HPD, Part No.8496200, MEVATRON KD-2 / HPD, Part No.8515520, MEVATRON M3 6300 / HPD, Part No.9401316, MEVATRON M2 6700 / HPD, Part No.9401407, MEVATRON M2 6740 / HPD, Part No.9401506, MEVATRON KDS / HPD, Part No.941522, MEVATRON MD-2 / HPD, Part No.9401654, MEVATRON MDX 2 / HPD, Part No.9401746, MEVATRON KDS-2 / HPD, Part No.9411588, MEVATRON KD-2 / HPD, Part No.9822685, MEVATRON KDS-2 / HPD, Part No.9822693

    FDA Recall
    Terminated ·Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510 4040 Nelson Ave Concord CA 94520-1200·Product code IYE·August 13, 2010

    COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·March 4, 2015

    Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·April 4, 2018

    Linear accelerator workstation software suite

    FDA Recall
    Terminated ·Varian Medical Systems Inc·Product code IYE·May 27, 2004

    TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 13, 2021

    LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·July 2, 2014