Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VERO Linear Accelerator System Recalled by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK Due to Software Anomaly: If a user changes the calendar...
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 Linear Accelerator System, Model Number MHI-TM2000; 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: 3 units in use in the US
Why Was This Recalled?
Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed) status on the exact day when such change is made, to Untreated status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as Untreated treatment
Where Was This Sold?
This product was distributed to 3 states: FL, NY, TX
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