• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ProBeat Proton Therapy System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ProBeat Proton Therapy Systemsee related information
Date Initiated by FirmMay 09, 2014
Date PostedJune 21, 2014
Recall Status1 Terminated 3 on November 12, 2014
Recall NumberZ-1846-2014
Recall Event ID 68384
510(K)NumberK133191 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductProBeam 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
ActionVarian 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 Commerce1
DistributionUS Distribution in tthe state of CA
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 = LHN
-
-