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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