FDA-Device2018-05-09Class II
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.
Hitachi Ltd., Medical System Operations Group
Hazard
Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
Sold states
US Distribution in the state of NY.
Affected count
1
Manufactured in
2-1, Shintoyofuta, Kashiwa, N/A, Japan
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1585-2018Don't want to check this manually?
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