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. The VERO MHI-TM2000 Operator Console may...
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, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Quantity: Domestic: 4 units
Why Was This Recalled?
Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port
Where Was This Sold?
This product was distributed to 4 states: FL, NY, OH, 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