Class II — Potential Health Hazard

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 3.5.0 and 3.5.1) Recalled by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK Due to The operator console allows users to deliver therapeutic...

Date: April 17, 2015
Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Status: Terminated
Source: FDA (Device)

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 3.5.0 and 3.5.1)

Quantity: 11 units total

Why Was This Recalled?

The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.

Where Was This Sold?

This product was distributed to 4 states: FL, NY, OH, TX

Affected (4 states)Not affected

About MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report