MHI-TM2000 Linear Accelerator System: Cl II

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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