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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 Firm December 08, 2017
Create Date May 01, 2018
Recall Status1 Terminated 3 on April 11, 2019
Recall Number Z-1585-2018
Recall Event ID 79439
510(K)Number K152867  K122450  K072047  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MHI-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
Action Hitachi 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 Commerce 1
Distribution US Distribution in the state of NY.
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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