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U.S. Department of Health and Human Services

Class 2 Device Recall Barcode Conical Collimator Verification (BCCV)

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  Class 2 Device Recall Barcode Conical Collimator Verification (BCCV) 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-0716-2012
Recall Event ID 60826
510(K)Number K103394  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Varian brand Barcode Conical Collimator Verification (BCCV) v1.0, Reference/FSCA Identifier: CP-06873, Model Number: HB, distributed by and/or 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 
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 9
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, ONCOLOGY SYSTEMS
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