Manufacturers

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

6 devices in the database

Device Recall VERO Linear Accelerator System
  • Model / Serial
    Serial Numbers: 201902, 203901, 203919, and 203924 (US only)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of NY, FL, TX and OH.
  • Product Description
    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Device Recall MHITM2000/VERO
  • Model / Serial
    Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.
  • Product Description
    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.
Device Recall VERO
  • Model / Serial
    Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including New York, Texas, Florida, and Ohio
  • Product Description
    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.
MHITM2000 Linear Accelerator System
  • Model / Serial
    Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
  • Product Description
    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Device Recall MHITM2000/ VERO (TM)
  • Model / Serial
    Serial Numbers #s 201902 and 203901
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.
  • Product Description
    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
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