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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 Systemsee related information
Date Initiated by FirmApril 17, 2015
Date PostedMay 01, 2015
Recall Status1 Terminated 3 on April 11, 2017
Recall NumberZ-1574-2015
Recall Event ID 70638
510(K)NumberK072047 K122450 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductMHI-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)
ActionMITSUBISHI 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 Commerce11 units total
DistributionWorldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYE
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