Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK.
Date of Enforcement Report: 5/13/2015
Class lI:

PRODUCT

MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Recall Number Z-1574-2015

REASON
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.

RECALLING FIRM/MANUFACTURER
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, HIROSHIMA, JP on 4/17/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
11

DISTRIBUTION
Nationwide and Internationally

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