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U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy Mx Radiotherapy Delivery System

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  Class 2 Device Recall Trilogy Mx Radiotherapy Delivery System see related information
Date Initiated by Firm May 19, 2011
Date Posted July 08, 2011
Recall Status1 Terminated 3 on March 13, 2012
Recall Number Z-2766-2011
Recall Event ID 58994
510(K)Number K092871  
Product Classification Accelerator, linear, medical - Product Code IYE
Product TrueBeam Linear Accelerators (aka Trilogy Mx)
Varian Medical Systems, Palo Alto, CA

Product Usage: 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 numbers: H14, H19, H27, H29. Serial numbers: H191001 H191012 H191022 H191032 H191043 H191054 H191066 H191083 H191002 H191013 H191023 H191033 H191044 H191055 H191067 H191085 H191003 H191014 H191024 H191034 H191045 H191056 H191070 H191086 H191005 H191015 H191025 H191035 H191046 H191057 H191071 H191089 H191006 H191016 H191026 H191036 H191047 H191058 H191072 H191090 H191007 H191017 H191027 H191037 H191048 H191059 H191076 H191091 H191008 H191018 H191028 H191038 H191049 H191060 H191077 H191092 H191009 H191019 H191029 H191039 H191051 H191061 H191078  H191010 H191020 H191030 H191041 H191052 H191063 H191079  H191011 H191021 H191031 H191042 H191053 H191064 H191080  
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
650-424-6471
Manufacturer Reason
for Recall		 Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.
FDA Determined
Cause 2		 Device Design
Action Varian Medical Systems, Inc. Oncology Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 19, 2011, via certified mail, return receipt requested in the US. The letter identified the product, problem and recommended actions to be taken. For additional information contact Varian Customer Support at 1-888- 827-4265.
Quantity in Commerce 77
Distribution Worldwide Distribution -- USA (nationwide) and countries of: Canada, Denmark, France, Germany, Isreal, Italy, Netherlands, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and 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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