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U.S. Department of Health and Human Services

Class 2 Device Recall MHITM2000 Linear Accelerator System

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  Class 2 Device Recall MHITM2000 Linear Accelerator System see related information
Date Initiated by Firm April 17, 2015
Date Posted May 01, 2015
Recall Status1 Terminated 3 on April 11, 2017
Recall Number Z-1574-2015
Recall Event ID 70638
510(K)Number K072047  K122450  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Code Information Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 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		 The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action MITSUBISHI HEAVY INDUSTRIES, LTD. has issued a Safety Alert for the MHI-TM2000 Linear Accelerator System dated April 10, 2015, due to a software issue. Customers were advised not to deliver therapeutic X-ray if popup warning message show is displayed during treatment. Instructions were provided if therapeutic radiation is delivered during popup warning. Customers with questions should contact the Customer Service Representative by calling 1-800-597-5911, Monday through Friday or email: us.support@brainlab.com. **CAPA** Correction software for this issue has a tentative availability date of June 2015. Estimated software update completion date would be end of October 2015.
Quantity in Commerce 11 units total
Distribution Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
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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