Reported May 9, 2018 · Terminated
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation…
Hitachi Ltd., Medical System Operations Group
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Ltd., Medical System Operations Group · 2-1 · Kashiwa, N/A · N/A
Is this the product you have?
- MHI-TM2000
- Linear Accelerator System Product UsageMHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated
- Lot codes and dates
- Serial Number203919
- Amount recalled
- 1
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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