Events

Device Recall Varian 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
    62562
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2153-2012
  • 사례 시작날짜
    2012-07-02
  • 사례 출판 날짜
    2012-08-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111025
  • 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
    A software anomaly has been identified with the import export application version 11.0 where mlc leaf positions for plans using brainlab m3 and mmlc are incorrectly imported.
  • 조치
    Varian Medical Systems sent a " Urgent Medical Device Correction Urgent Field Safety Notice" dated July 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed until a correction is deployed all treatment plans using the BrainLab m3 mMLC must be imported using the Import Wizard only. Varian Medical Systems is developing a technical correction for this issue. You will be contacted by a Customer Service Representative when this correction is available to schedule its installation on your system. For further questions please call 1.888.827.4265.

Device

Device Recall Varian
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers/CODES: HIT0535, HIT2953
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of New York and Ohio.
  • 제품 설명
    Varian brand Varian ARIA Oncology Information System, Import Export || application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.
  • 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