Reported May 13, 2015 · Terminated

MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK · 6-22, 4-CHOME, KAN-ON-SHIN-MACHI · HIROSHIMA, N/A · N/A

Is this the product you have?

  • MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Lot codes and dates
  • Serial Numbers
    • 201902
    • 201903
    • 202903
    • 202905
    • 203901
    • 203902
    • 203903
    • 203905
    • 203906
    • 203919 & 203924
Amount recalled
11 units total

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 11, 2017 · Data as of Sep 19, 6:47 PM UTC

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