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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 December 02, 2014
Date Posted December 17, 2014
Recall Status1 Terminated 3 on June 26, 2017
Recall Number Z-0821-2015
Recall Event ID 69825
510(K)Number K072047  K122450  
Product Classification Accelerator, linear, medical - Product Code IYE
Product VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Code Information Serial Numbers: 201902, 203901, 203919, and 203924 (US only)
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. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port
FDA Determined
Cause 2		 Software design
Action Mitsubishi sent a Field Safety Notice dated November 14, 2014, that was e-mailed to US end users on December 2, 2014, which provided actions to be taken by the end users. If users need any further information or support concerning this issue, they may contact MHI's Customer Service Representative, Brainlab AG in Germany, contact person: Franz Gum, Tel: +49-89-99-1568-0, Fax: +49-89-99-1568-33, E-mail: Franz.Gum@brainlab.com. If any other abnormality is detected, stop operation and contact MHI's Customer Service representative immediately. --- An Updated Field Safety Notice (dated December 4, 2014,) was sent to end users to correct some terms used in the initial notification.
Quantity in Commerce Domestic: 4 units
Distribution US Distribution to the states of NY, FL, TX and OH.
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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