Hitachi Ltd., Medical System Operations Group recalls MHI-TM2000 Linear Accelerator System Product Usage: MHI-
Recalled Product
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.
Hazard / Issue
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.
Issued by
FDA
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