Events

Device Recall Varian brand Eclipse Treatment Planning System 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
    60837
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0736-2012
  • 사례 시작날짜
    2011-12-12
  • 사례 출판 날짜
    2012-01-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106612
  • 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
    System,planning,radiation therapy treatment - Product Code MUJ
  • 원인
    An anomaly has been identified with the eclipse treatment planning system when planning for the siemens multileaf collimator (mlc) where a virtual jaw can be positioned inside the mlc aperture and then used as the beam limiting device for the dose calculation. this will result in an incorrect dose distribution within eclipse.
  • 조치
    Varian Medical Systems sent a Urgent Medical Device Correction letter dated December 12, 2011, to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to pay careful attention to any warnings displayed regarding the Virtual Collimator Jaws when the plan is calculated. If the warning indicates that the Virtual Collimator Jaws are inside the MLC aperture, do not proceed with the calculation. Varian is continuing to evaluate possible technical solutions for this issue. Special Instructions for customers outside the USA and Canada: In order to satisfy regulatory requirements, we request that you complete the attached Proof of Notification or Receipt Verification Card once you have read this document and return it to Varian Medical Systems. "We sincerely apologize for any inconvenience and thank you in advance for your cooperation." Please call for USA and Canada: 1.888.VARIAN5 (888.827.4265) Europe: +41 41 749 8844.

Device

Device Recall Varian brand Eclipse Treatment Planning System
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Worldwide Distribution -- USA (nationwide) including the countries of Canada and Europe.
  • 제품 설명
    Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; || Reference/FSCA Identifier: CP-07007, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye.
  • 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