Class 2 Device Recall MHITM2000/VERO

• Date Initiated by Firm: December 15, 2015
• Date Posted: March 24, 2016
• Recall Status: Terminated on April 20, 2017
• Recall Number: Z-1244-2016
• Recall Event ID: 72991
• 510(K)Number: K072047 K122450 K152867
• Product Classification: Accelerator, linear, medical - Product Code IYE
• 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.
• Code Information: Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929.
• 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: 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.
• FDA Determined Cause: Software design
• Action: 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" if all the following conditions are met: (1) At least one patient has been treated on the day; (2) A major error occurs when VeroTM/MHI-TM2000 is operated in a mode, other than Clinical Mode, which means Daily Check Mode or Maintenance Mode. (3) The major error is NOT associated with a function that uses therapeutic/ MV radiation parameters, such as an error in Isocenter Check function, etc. Note 1: If the major error is associated with a function that uses therapeutic/MV radiation parameters, the problem that treatment completion status is changed will never occur. The Operator Console changes the treatment completion status in the course of processing the major error. Note 2: Although treatment completion status is changed to "Untreated", its delivered dose result has been correctly saved into R&V System. It has not been lost. Advice on Actions by Customer/Users: 1. Please make sure to perform the operations as described below in case a major error occurred in a mode other than Clinical Mode. (1) Cancel the error. (2) Click [Clinical] button on the left of Operator Console screen. (3) Verify, on R&V System screen, that treatment completion status of the patients who were treated on the day are all correct. The treatment completion status is indicated in different colors as follows depending on the status: Untreated: BLUE, Completed: GRAY, Discontinued: RED. Customers requiring support concerning this issue, please contact the Customer Service Representative: 1-800-597-5911 (Mon - Fri) or via email us.support@brainlab.com. If any other problem is detected, please stop operation and contact the Customer Service representative.
• Quantity in Commerce: 25 devices (4 domestically in U.S.A. and 21 internationally)
• Distribution: Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.
• 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.