MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK recalls MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

Recall date

April 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1574-2015

FDA classification

Class II

Brand / firm

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Sold / distributed

Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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