BEUDAMED
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    Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.

    FDA Recall
    Terminated ·Steris Corporation·Product code MDZ·February 19, 2015

    Ultacell Diamond Knife Cleaning Block 15mm Catalog #: 40462

    FDA Recall
    Terminated ·Ultracell Medical Technologies·Product code MDZ·January 8, 2003

    MultiDiagnost MD4

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    MultiDiagnost MD3

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    MD4 X-ray system

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·April 6, 2006

    MD3 X-ray system

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·April 6, 2006

    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

    MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, 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

    Mevatron MD2 Medical Linear Accelerator, Material Number: 09401654, 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 MD-2; 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

    Siemens Mevatron MD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 09401654, Siemens Medical Solutions, Concord, CA 94520

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

    Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 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

    Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977; Mevatron M 6700, Part No.: 5693908; Mevatron M 6730, Part No.: 5694005; Mevatron M 7140, Part No.: 5694104; Mevatron M 7400, Part No.: 5694153; Mevatron M 7445, Part No.: 5694203; Mevatron M 6300, Part No.: 8317000; Mevatron M 6740, Part No.: 8319758; Mevatron MD, Part No.: 8319808; Mevatron ME, Part No.: 8490005; Mevatron MDX, Part No.: 8496200; Mevatron M2 6300, Part No.: 9401316; Mevatron M-2 6700, Part No.: 9401407; Mevatron M2 6740, Part No.: 9401506; Mevatron MD2, Part No.: 09401654; and Mevatron MDX-2, Part No.: 9401746 Siemens Medical Solutions USA, Inc., Concord, CA

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

    MEVATRON MD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401654,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

    STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4) S2V-20, STAT 2¿ Primary Administration Set Gravity Flow Controller, 20 Drops/ml, 84 length, and (5) S2V-60, STAT 2¿ Primary Administration Set Gravity Flow Controller, 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·March 7, 2018

    MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, 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 Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 25, 2017

    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 Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 19, 2014

    Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2, MEVATRON KD, MEVATRON KDS, MEVATRON 77, MEVATRON K7467, MEVATRON 7767, MEVATRON K8067, MEVATRON M 6300 (MX), MEVATRON M 6730, MEVATRON M 7140, MEVATRON M 7400, MEVATRON MDX, MEVATRON MD (MD, MDX), MEVATRON M 7445 (MXE), MEVATRON M 7400/7440 (MXE), MEVATRON M 6730/6740 (MXE), MEVATRON M 6700 (MX): 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 Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 2, 2014

    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

    Theratron Elite 80 Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004