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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 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

    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

    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

    Linear accelerator workstation software suite

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

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

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IXI·January 18, 2013

    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 Recall
    Terminated ·Accuray Incorporated·Product code IYE·December 10, 2020

    TomoTherapy Treatment Delivery System with iDMS - 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 Recall
    Terminated ·Accuray Incorporated·Product code IYE·December 10, 2020

    Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 10, 2011

    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 Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·March 4, 2015

    Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability

    FDA Recall
    Terminated ·Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304-1030·Product code IYE·February 4, 2005

    BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany. The mMLC 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

    Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Alto, CA

    FDA Recall
    Terminated ·Varian Medical Systems Inc·Product code IYE·October 2, 2007

    Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model Number(s): All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator 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 excess radiation.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·January 16, 2012