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U.S. Department of Health and Human Services

Class 2 Device Recall TrueBeam Radiotherapy Delivery System

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  Class 2 Device Recall TrueBeam Radiotherapy Delivery System see related information
Date Initiated by Firm January 30, 2012
Date Posted March 06, 2012
Recall Status1 Terminated 3 on April 16, 2014
Recall Number Z-1175-2012
Recall Event ID 61196
510(K)Number K111106  
Product Classification Accelerator, linear, medical - Product Code IYE
Product TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Code Information Model H19: Code numbers:  H191182,H191035,H191150,H191100,H191103,H191040,H191072,H191065, H191089,H191116,H191068,H191160,H191141,H191113,H191027,H191145, H191026,H191093,H191054,H191189,H191129,H191090,H191197,H191022,H191063,H191010,H191162,H191078,H191098,H191142,H191066,H191005,H191018,H191076,H191188,H191048,H191137,H191064,H191153,H191044,H191151,H191046,H191136,H191067,H191031,H191077,H191158,H191028,H191156,H191088,H191132,H191009,H191069,H191085,H191186,H191101,H191094,H191039,H191124,H191073,H191183,H191008,H191133,H191016,H191003,H191071,H191175,H191152,H191168,H191099,H191166,H191029,H191036,H191155,H191092,H191034,H191043,H191045,H191074,H191170,H191130,H191055,H191147,H191178,H191114,H191107,H191164,H191047,H191015,H191091,H191019,H191038,H191163,H191203,H191110,H191061, H191049,H191179,H191096,H191079,H191106,H191017,H191154,H191006,H191024,H191108,H191149,H191052,H191199,H191023,H191117,H191033,H191104,H191131,H191011,H191118,H191087,H191109,H191053,H191187,H191126,H191191,H191042,H191080,H191161,H191105,H191012,H191025, H191115,H191111,H191140,H191020,H191013,H191169,H191127,H191086,H191144,H191095,H191125,H191002,H191112,H191021,H191138,H191014,H191135,H191139,H191097,H191032,H191102,H191119,H191128,H191060,H191001,H191198,H191057,H191122,H191146,H191157,H191143,H191083,H191180,H191121,H191181,H191123,H191081,H191165,H191176,H191056,H191120,H191082,H191041,H191070,H191134,H191148,H191030,H191058,H191007,H191177,H191051,H191172,H191059 and H191037,  *** 12-12-12, AMENDED INFO ***:  H191167, H191171, H191184, H191185, H191192, H191194, H191202, H191205, H191207, H191208, H191211, H191214, H191217, H191219, H191220, H191222, H191223, H191224***          
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Peter J. Coronado
650-424-6320
Manufacturer Reason
for Recall		 An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during planning.
FDA Determined
Cause 2		 Device Design
Action Urgent Medical Device Correction/Urgent Field Safety Notices were sent on January 30, 2012 by certified mail to US and Canadian consignees. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** Varian Sales, Marketing and Service Organizations also were informed via letter the same day. The Field Safety Notice with customer distribution list was e-mailed to Varian International Customer Support Managers for translation (if necessary) to be sent to affected sites with return proof of notification to be sent to Varian. The notice informed users of the recommended actions. Questions were directed to the Varian Help Desk 1-888-827-4265 (US and Canada).
Quantity in Commerce 182 units ***12-12-12 AMENDED TO: 200 units***
Distribution Nationwide Distribution (USA) and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, New Zealand, Norway, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, Turkey and the United Kingdom.
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 = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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