FDAApril 17, 2015device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

mitsubishi heavy industries ltd hiroshima machinery workmitsubishimitsubishi heavy

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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