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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LHN
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