24

Sep

2014

Cl II VERO (TM) Linear Accelerator System

0

Company: MITSUBISHI HEAVY INDUSTRIES, LTD.
Date of Enforcement Report: 9/24/2014
Class lI:

PRODUCT

VERO (TM) Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall Number Z-2653-2014

REASON
Software Anomaly: Due to certain software bug, if a user changes the calendar setting from “workday” to “holiday” or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become “treated (completed)” status on the exact day when such change is made, to “untreated” status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as “untreated” treatment.

RECALLING FIRM/MANUFACTURER
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK,
HIROSHIMA, Japan on 7/5/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
3 units in the US

DISTRIBUTION
Distributed in the states of NY, FL, and TX.

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About the author

Amy Sellers

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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