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    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·June 21, 2013

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·December 2, 2014

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014

    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·August 14, 2013

    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·March 7, 2016

    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·April 6, 2016

    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·December 6, 2017

    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Hitachi Ltd., Medical System Operations Group·May 9, 2018

    VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·September 24, 2014

    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

    FDA Recall
    Terminated ·Brainlab AG Olof-Palme-Strasse 9 Munich Germany·Product code IYE·November 3, 2017

    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·Hitachi Ltd., Medical System Operations Group 2-1 Shintoyofuta Kashiwa Japan·Product code IYE·December 8, 2017

    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·April 17, 2015

    VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·July 5, 2014

    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·May 13, 2015

    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·March 30, 2016

    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·December 15, 2015

    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems Inc.·Product code MHY·March 28, 2012

    Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay

    FDA Recall
    Terminated ·Genzyme Diagnostics·Product code MHI·February 23, 2004

    Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code MHY·September 30, 2013

    Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code MHY·September 12, 2017