Events

Device Recall Barcode Conical Collimator Verification (BCCV) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems, Inc. Oncology Systems 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    60826
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0716-2012
  • 사례 시작날짜
    2011-12-12
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106588
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Accelerator, linear, medical - Product Code IYE
  • 원인
    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.
  • 조치
    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.

Device

Device Recall Barcode Conical Collimator Verification (BCCV)
  • 모델명 / 제조번호(시리얼번호)
    ,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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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..
  • 제품 설명
    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.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • 제조사 주소
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA