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U.S. Department of Health and Human Services

Class 2 Device Recall MHITM2000/ VERO"

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 Class 2 Device Recall MHITM2000/ VERO"see related information
Date Initiated by FirmDecember 08, 2017
Create DateMay 01, 2018
Recall Status1 Terminated 3 on April 11, 2019
Recall NumberZ-1585-2018
Recall Event ID 79439
510(K)NumberK072047 K122450 K152867 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductMHI-TM2000 Linear Accelerator System Product Usage: 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 Serial Number: 203919
Recalling Firm/
Manufacturer		 Hitachi Ltd., Medical System Operations Group
2-1
Shintoyofuta
Kashiwa Japan
Manufacturer Reason
for Recall		Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
FDA Determined
Cause 2		Device Design
ActionHitachi sent a Field Safety Notice letter dated November 28, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter includes instructions for the user on how to verify patient position even with the software issue. The letter also explains that correction software is being developed with a tentative release date of, "End of January, 2018.". A customer service representative will contact affected customers about installing the software. For questions contact your our Customer Service Representative.
Quantity in Commerce1
DistributionUS Distribution in the state of NY.
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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