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Hitachi Ltd., Medical System Operations Group recalls MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation t
Recalled May 9, 2018 · FDA recall Z-1585-2018 · 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. · FDA Class II
Units
1
Sold at
US Distribution in the state of NY.
Description
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.
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.
Manufacturer(s)
Hitachi Ltd., Medical System Operations Group
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →