BEUDAMED
    4 results · 89ms · Sources: EU EUDAMED, US FDA

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    MRI SCANNER

    FDA Adverse Event
    Injury ·HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP·Product code LNH·March 30, 2021

    HITACHI OASIS 1.2 TESLA MRI MACHINE

    FDA Adverse Event
    Injury ·HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP·Product code LNH·September 10, 2019

    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

    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