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MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK recalls MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumo
Recalled March 30, 2016 · FDA recall Z-1244-2016 · MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
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. · FDA Class II
Units
25 devices (4 domestically in U.S.A. and 21 internationally)
Sold at
Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.
Description
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.
Product
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.
Manufacturer(s)
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →