Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System Recalled by Hitachi Ltd., Medical System Operations Group Due to Due to a system controller software anomaly, the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hitachi Ltd., Medical System Operations Group directly.
Affected 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.
Quantity: 1
Why Was This 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.
Where Was This Sold?
This product was distributed to 1 state: NY
About Hitachi Ltd., Medical System Operations Group
Hitachi Ltd., Medical System Operations Group has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report