Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended Recalled by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK Due to Due to Operator Console software anomaly, a change...
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
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
Quantity: 25 devices (4 domestically in U.S.A. and 21 internationally)
Why Was This Recalled?
Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditions.
Where Was This Sold?
Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.
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