Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Recalled by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK Due to In rare cases the VERO/MHI-TM2000 Operator Console could...
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 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK directly.
Affected Products
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator 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: 25 Worldwide, US: 4 units
Why Was This Recalled?
In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report