BEUDAMED
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    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·January 18, 2017

    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 15, 2020

    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·December 21, 2016

    Siemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatron KD2, Part No.: 1940753; Mevatron KD2, Part No.: 08515520; Mevatron KD2-Part No.: 9822685; Mevatron K 7767, Part No.: 5694302; Mevatron K 8067, Part No.: 5694401; Mevatron KD, Part No.: 8319857; Mevatron KDS, Part No.: 9401522; Mevatron KDS2, Part No.: 9411588; and Mevatron KDS2, Part No.: 9822693, Siemens Medical Solutions USA, Inc., Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·July 27, 2007

    Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·February 18, 2020

    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·October 9, 2019

    MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 15, 2017

    bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code MDB·October 16, 2012

    bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code MDB·October 16, 2012

    bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code MDB·October 16, 2012

    LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. Product Usage: The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 11, 2015

    Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number:08515520, Siemens Medical Solutions, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·August 7, 2007

    Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Siemens Medical Solutions, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·August 7, 2007

    Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

    Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator, part number 1940753 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007

    MEVATRON KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 1940753, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

    Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

    Mevatron KD2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 1, 2011