FDADecember 15, 2015device

MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.

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

The hazard

Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditions.

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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