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U.S. Department of Health and Human Services

Class 2 Device Recall 4D Integrated Treatment Console (4DITC)

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  Class 2 Device Recall 4D Integrated Treatment Console (4DITC) see related information
Date Initiated by Firm December 12, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 05, 2013
Recall Number Z-0715-2012
Recall Event ID 60826
510(K)Number K091132  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3, Reference/FSCA Identifier: CP-06873,
Model Number: H51, distributed by and manufactured by:
Varian Medical Systems Inc., Palo Alto, CA

The 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS, planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Collimator Verification [BCCV] device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place.
Code Information ,HBC0001 , H512022 , H511551 , H511275 ,HBC0004 ,H512993 ,H513292 ,H515900 ,HBC0007 ,H512781 ,H513115 ,H511691 ,HBC0018 ,H512241 ,H515092 ,H513533 ,HBC0021 ,H513561 ,H514438 ,H515524 ,HBC0024 ,H510889 ,H512278 ,H513927 ,HBC0028 ,H515461 ,H515076 ,H514202 ,HBC0048 ,H510126 ,H513080 ,H515780 ,HBC0069 ,H515541 ,H512967 ,H515068 ,HBC0070 ,H511840 ,H513262 ,H510732 ,HBC0075 ,H514160 ,H513701 ,H511593 ,HBC0079 ,H513117 ,H513551 ,H514018 ,HBC0083 ,H511663 ,H511565 ,H512454 ,HBC0090 ,H513989 ,H515570 ,H515064 ,HBC0097 ,H512618 ,H512464 ,H515737 ,HBC0106 ,H514439 ,H515943 ,H515696 ,HBC0111 ,H515691 ,H511821 ,H515523 ,HBC0115 ,H515998 ,H514402 ,H514521 ,HBC0174 ,H515387 ,H514403 ,H513548 ,HBC0210 ,H513769 ,H514080 ,HBC0211 ,H515262 ,H513002 ,HBC0348 ,H514488 ,H512998  AMENDED to include additional serial numbers on 12/12/12: H511303 H511424 H514101 H515394 H51B363 H512492 H511683 H514099 H515656 H51B390 H510942 H511703 H514102 H515413 H51B393 H511878 H511881 H514115 H515446 H51B486 H512433 H511865 H514126 H515454  H512507 H511937 H514158 H515467  H512744 H511964 H514184 H515492  H513069 H511963 H514186 H515500  H513095 H512146 H514192 H515501  H513249 H512134 H514213 H515499  H513307 H512255 H514212 H515511  H513786 H512253 H514266 H515512  H514145 H512287 H514277 H515521  H514359 H512445 H514282 H515531  H514662 H512452 H514278 H515561  H515039 H512520 H515288 H515574  H515060 H512613 H514332 H515583  H515102 H513477 H514365 H515587  H515181 H514930 H514382 H515588  H515346 H512704 H514417 H515601  H515509 H512930 H514461 H515620  H515619 H512980 H514464 H515635  H515681 H513004 H514479 H515689  H515678 H513009 H515363 H515718  H515739 H513051 H514523 H515727  H515878 H513064 H514517 H515751  H51B131 H513081 H514544 H515759  H51B132 H513114 H513510 H515764  H51B136 H513133 H514609 H515797  H51B470 H513152 H514615 H515800  H510451 H513202 H514621 H515804  H518106 H513276 H515017 H515815  H513460 H513279 H514649 H515819  H514463 H513298 H515034 H515829  H510408 H513300 H515033 H515835  H512385 H513340 H514669 H515849  H512506 H513379 H514678 H515874  H51B197 H514552 H515004 H515876  H51A018 H513554 H515031 H515879  H514671 H513591 H515044 H515897  H510004 H513606 H515050 H515901  H511612 H513648 H515051 H515931  H513127 H513692 H515095 H515941  H512940 H513700 H515104 H515947  H518178 H510966 H515115 H515966  H510074 H513770 H515138 H515984  H513471 H513801 H515169 H515987  H514637 H513826 H515191 H51B011  H511748 H513825 H515204 H51B034  H510855 H513838 H515211 H51B055  H510915 H513891 H515221 H51B098  H511720 H513888 H515224 H51B153  H512240 H513894 H515231 H51B154  H512308 H514001 H515259 H51B204  H511012 H514017 H515282 H51B248  H511002 H514021 H515295 H51B251  H511313 H514069 H515304 H51B285  H511399 H514079 H515317 H51B299. 
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Peter J. Coronado
650-424-5731
Manufacturer Reason
for Recall		 When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, the name of the plan is not being updated correctly.
FDA Determined
Cause 2		 Device Design
Action The firm, VARIAN Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" dated December 12, 2011, to all affected customers. The notice described the product, problem and user corrective action steps. The customers were provided to do the following: Do not use BCCV as a primary reference for identifying the correct plan to be treated; use caution when selecting an isocenter in a positioning system that is not interfaced to the 4DITC; any discrepancies in planned versus actual parameters should be brought to the attention of the medical physicist for investigation before treatment begins, and one workaround is to schedule one plan per session. Special instructions for customers outside the USA and Canada: complete the attached Proof of Notification or Receipt Verification Card once you have read this document and return it to Varian Medical Systems. Varian is developing a technical correction for this issue. The customers will be contacted by a customer representative when this technical correction is available to schedule installation on their system. If you require further clarification, please feel free to call your local Varian Customer Support District or Regional Manager: USA and Canada: 1-888-827-4265; Europe: +41 41 749 8844; Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: support-sea@varian.com; China/Asia: support-china@varian.com; Japan: support-japan@varian.com and Latin America: soporte.al@varian.com; and Internet: www.myvarian.com or www.varian.com. Additional recall letters were sent on 11/5/12 to additional consignees that Varian determined needed to be notified of the recall.
Quantity in Commerce 55
Distribution Worldwide distribution:USA (nationwide) and countries of: Canada, Australia, Austria, Brazil, China, France, Georgia, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Macau. Malaysia, Mexico, Netherlands, Singapore, Slovenia, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, 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
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