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U.S. Department of Health and Human Services

Class 2 Device Recall Proton beam therapy system

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  Class 2 Device Recall Proton beam therapy system see related information
Date Initiated by Firm April 21, 2015
Date Posted July 18, 2015
Recall Status1 Terminated 3 on March 24, 2016
Recall Number Z-1838-2015
Recall Event ID 71056
510(K)Number K073059  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM

Product Usage:
Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Code Information No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability
Recalling Firm/
Manufacturer		 Hitachi America, Ltd., Power Systems Division
1840 Old Spanish Trl
Houston TX 77054-2002
For Additional Information Contact
713-563-7593 Ext. 19
Manufacturer Reason
for Recall		 At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.
FDA Determined
Cause 2		 Device Design
Action The recalling firm notified the one consignee about the incident that occurred in Japan on 4/7/15, then gave them an update on 4/13/15 and 4/21/15. The written notification had details for the consignee on how to prevent the device from malfunctioning. The recalling firm also had held conversations with the consignee to discuss the issue and revised work instructions via telephone conference and on site Hitachi personnel.
Quantity in Commerce 3
Distribution Distribution in US (Texas) and Japan
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 = LHN and Original Applicant = HITACHI, LTD., POWER SYSTEMS GROUP
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