Device Recall VERO

  • Model / Serial
    Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924
  • Product Classification
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA Japan
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial Numbers: 201902, 203901, 203919, and 203924 (US only)
  • Product Classification
  • 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.
  • Manufacturer
  • Model / Serial
    Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of NY, FL, and TX.
  • Product Description
    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.
  • Manufacturer