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U.S. Department of Health and Human Services

Class 2 Device Recall MHITM2000/ VERO (TM)

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 Class 2 Recall
MHITM2000/ VERO (TM)
see related information
Date Posted August 08, 2013
Recall Status1 Open
Recall Number Z-1931-2013
Recall Event ID 65786
Premarket Notification
510(K) Numbers
K072047  K122450 
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); 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 Serial Numbers #s 201902 and 203901
Recalling Firm/
Manufacturer
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
6-22, 4-CHOME, KAN-ON-SHIN-MACHI
NISHI-KU
HIROSHIMA
Consumer Instructions Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.
For Additional Information Contact Katsuhisa Toyama
212-3976128
Manufacturer Reason
for Recall
Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action The firm, Mitsubishi Heavy Industries, Ltd. (MHI), sent an "URGENT FIELD SAFETY NOTICE" letter dated June 21, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: If any minor failure occurs, please always press [ALARM RESET] button on operator console first; and if [EXIT] button is clicked after a minor failure occurs, please click [YES] on the pop up dialog to finish treatment completely. MHI is developing a correction for this issue. Tentatively planned availability date: End of October 2013. The correction will be free of charge and a MHI Customer Service representative will contact affected customers to schedule its installation as the correction becomes available. If you need any further information or support concerning this issue, please feel free to contact our Customer Service representative: VERO GmbH, Kapellenstrasse 12, 8566 Feldkirchen Germany, at +49-89-99-1568-44 or email: franz.gum@vero-sbrt.com.
Quantity in Commerce 14 (2 in US)
Distribution Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = MITSUBISHI HEAVY INDUSTRIES, LTD.
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