Events

Device Recall Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc 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
    65418
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1663-2013
  • 사례 시작날짜
    2013-05-29
  • 사례 출판 날짜
    2013-07-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118861
  • 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
    The information regarding the film mode calibration may have been considered difficult to interpret when translated. siemens healthcare cr / radiation oncology had become aware that this issue may have resulted in mistreatment of patients.
  • 조치
    Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION" letter and Update instruction TH022/13/S beginning on May 29, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. July 19, 2013 - TH023/13/S was distributed is now in progress. This is the FILM Mode Physics Primer Addendum.

Device

Device Recall Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Li...
  • 모델명 / 제조번호(시리얼번호)
    All customers who use the BEAMVIEW for position verification imaging on Siemens MEVATRON series, PRIMART (limited release) PRIMUS and/or ONCOR or ARTIST Linac Systems.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA Nationwide and countries of: Algeria, Angola, Argentina, Austria, Australia, Bahamas, Belgium, Bosnia Herzeg, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hungary, India, Indonesia, Italy, Iran, Iraq, Ireland, Japan, Jordan, Kenya, DPR of Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Pakistan, Palestinian Ter, Peru, Philippines, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sri Lanka, South Africa, Sweden, Switzerlan, Taiwan, Thailand, Trinidad Tobago,Turkey, United Kingdom, Venezula, Vietnam, Rep of Yemen, and Zambia.
  • 제품 설명
    Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. || The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 757 Arnold Dr Ste A, Martinez CA 94553-3615
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA