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U.S. Department of Health and Human Services

Class 2 Device Recall TrueBeam and TrueBeam STx

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  Class 2 Device Recall TrueBeam and TrueBeam STx see related information
Date Initiated by Firm April 09, 2012
Date Posted May 16, 2012
Recall Status1 Terminated 3 on April 16, 2014
Recall Number Z-1617-2012
Recall Event ID 61694
510(K)Number K111106  
Product Classification Accelerator, linear, medical - Product Code IYE
Product TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. Varian Medical Systems, Palo Alto, CA.
Code Information Model number H19; Serial numbers: H191001 H191061 H191121 H191180 H191002 H191063 H191122 H191181 H191003 H191064 H191123 H191182 H191005 H191065 H191124 H191183 H191006 H191066 H191125 H191184 H191007 H191067 H191126 H191185 H191008 H191068 H191127 H191186 H191009 H191069 H191128 H191187 H191010 H191070 H191129 H191188 H191011 H191071 H191130 H191189 H191012 H191072 H191131 H191190 H191013 H191073 H191132 H191191 H191014 H191074 H191133 H191192 H191015 H191076 H191134 H191194 H191016 H191077 H191135 H191195 H191017 H191078 H191136 H191197 H191018 H191079 H191137 H191198 H191019 H191080 H191138 H191199 H191020 H191081 H191139 H191201 H191021 H191082 H191140 H191202 H191022 H191083 H191141 H191203 H191023 H191084 H191142 H191205 H191024 H191085 H191143 H191206 H191025 H191086 H191144 H191207 H191026 H191087 H191145 H191209 H191027 H191088 H191146 H191210 H191028 H191089 H191147 H191213 H191029 H191090 H191148 H191215 H191030 H191091 H191149 H191221 H191031 H191092 H191150 H191225 H191032 H191093 H191151 H191226 H191033 H191094 H191152 H191227 H191034 H191095 H191153 H191228 H191035 H191096 H191154  H191036 H191097 H191155  H191037 H191098 H191156  H191038 H191099 H191157  H191039 H191100 H191158  H191040 H191101 H191159  H191041 H191102 H191160  H191042 H191103 H191161  H191043 H191104 H191162  H191044 H191105 H191163  H191045 H191106 H191164  H191046 H191107 H191165  H191047 H191108 H191166  H191048 H191109 H191167  H191049 H191110 H191168  H191051 H191111 H191169  H191052 H191112 H191170  H191053 H191113 H191171  H191054 H191114 H191172  H191055 H191115 H191174  H191056 H191116 H191175  H191057 H191117 H191176  H191058 H191118 H191177  H191059 H191119 H191178  H191060 H191120 H191179   12/7/12 - Amended to include additional lot numbers: H191208, H191211, H191214, H191217, H191219, H191220, H191222 H191223, H191224. 
Recalling Firm/
Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Peter J. Coronado
Manufacturer Reason
for Recall
Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the operator should be aware of.
FDA Determined
Cause 2
Labeling design
Action An "Urgent Medical Device Correction / Field Safety Letter" was distributed to all affected users on April 9, 2012, with a description of the problem and user corrective action steps. The Letter was also distributed to the Varian Sales, Marketing, and Service organizations. Customers in the US and Canada may contact (888) 827-4265 for questions. *** An additional letter was sent on 11/5/12 to additional consignees identified by Varian as being affected the the recall but not previously notified.
Quantity in Commerce 207 devices 12/7/12 - amended to 216 devices.
Distribution Worldwide Distribution -- USA, and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Netherlands, New Zealand, Norway, Portugal, Russia, Saudi Arabia, South Korea, 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.