Company: MITSUBISHI HEAVY INDUSTRIES, LTD.,.
Date of Enforcement Report 3/30/2016
Class lI:

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.
Recall Number Z-1244-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA on 3/24/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
25 devices

DISTRIBUTION
Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.

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