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U.S. Department of Health and Human Services

Class 2 Device Recall ProBeat Proton Therapy System

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  Class 2 Device Recall ProBeat Proton Therapy System see related information
Date Initiated by Firm May 09, 2014
Date Posted June 21, 2014
Recall Status1 Terminated 3 on November 12, 2014
Recall Number Z-1846-2014
Recall Event ID 68384
510(K)Number K133191  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product ProBeam Proton Therapy System (HGA and HFB)

Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
Code Information Codes: HFB0031, HGA0032, HGA0033, HGA0034, HFB0035.
Recalling Firm/
Manufacturer		 VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
FRIEDRICH-EBERT-STR. 1
BERGISCH GLADBACH Germany
Manufacturer Reason
for Recall		 Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database.
FDA Determined
Cause 2		 Under Investigation by firm
Action Varian sen an Urgent Device Medical Correction/Urgennt Field Safety Notice letter dated May 9, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions cotact Varian Service Support. at debg-PT-service-support@varian.com.
Quantity in Commerce 1
Distribution US Distribution in tthe state of CA
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 = VARIAN MEDICAL SYSTEMS
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