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U.S. Department of Health and Human Services

Class 2 Device Recall VERO Linear Accelerator System

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  Class 2 Device Recall VERO Linear Accelerator System see related information
Date Initiated by Firm July 05, 2014
Date Posted September 16, 2014
Recall Status1 Terminated 3 on April 01, 2015
Recall Number Z-2653-2014
Recall Event ID 68909
510(K)Number K072047  K122450  
Product Classification Accelerator, linear, medical - Product Code IYE
Product VERO 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.
Code Information Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
Recalling Firm/
Manufacturer		 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
6-22, 4-CHOME, KAN-ON-SHIN-MACHI
NISHI-KU
HIROSHIMA Japan
Manufacturer Reason
for Recall		 Software Anomaly: 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
FDA Determined
Cause 2		 Software design
Action A Preliminary Customer Information Letter (dated 7/4/14) was emailed to customers on 7/05/14 from Mitsubishi's sales and service representative in Germany. The letter informed customers of the potential safety issue associated with the VERO Linear Accelerator and the recommended actions to be taken. A formal URGENT FIELD SAFETY NOTICE Letter (dated 7/15/14) was emailed to customers on 8/07/14 from Mitsubishi's sales and service representative in Germany. The letter instructed customers to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions to be taken.
Quantity in Commerce 3 units in use in the US
Distribution Distributed in the states of NY, FL, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = MITSUBISHI HEAVY INDUSTRIES, LTD.
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