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U.S. Department of Health and Human Services

Class 2 Device Recall VERO

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  Class 2 Device Recall VERO see related information
Date Initiated by Firm March 07, 2016
Date Posted March 31, 2016
Recall Status1 Terminated 3 on April 20, 2017
Recall Number Z-1308-2016
Recall Event ID 73436
510(K)Number K072047  K122450  K152867  
Product Classification Accelerator, linear, medical - Product Code IYE
Product VERO MHI-TM2000 Linear Accelerator System --- 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 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924
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		 In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.
FDA Determined
Cause 2		 Software design
Action A Field Safety Notice dated March 2, 2016, was sent to all affected customers via e-mail on March 7, 2016. The Field Safety Notice informed users of the problem and provided a safe workaround until corrected software is available. The correction will be free of charge and a Customer Service Representative will contact all affected customers to schedule its installation. Customers with questions were advised to contact their Customer Service Representative.
Quantity in Commerce 25 Worldwide, US: 4 units
Distribution Nationwide Distribution including New York, Texas, Florida, and Ohio
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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