Events

Device Recall ARTISTE MV with Artiste Digital Linear Accelerators 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc., Concord, CA 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
    57704
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1422-2011
  • 사례 시작날짜
    2010-12-03
  • 사례 출판 날짜
    2011-02-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97050
  • 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 firm become aware of a potential issue with artiste system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient.
  • 조치
    The firm, Siemens, issued a "Customer Information" letter on December 3, 2010 via mail to all its direct consignees/customers. The letter described the product, problem and actions taken by the firm to the customer. Siemens arranged for an inspection of their customers systems to make sure the safety mechanism is fully functional. Siemens instructed the customers to include the Customer Information letter in their ARTISTE System Owner manual chapter 'Safety Advisory Letters' . If you any questions, please call 925-246-8407.

Device

Device Recall ARTISTE MV with Artiste Digital Linear Accelerators
  • 모델명 / 제조번호(시리얼번호)
    Serial No. 5647 - 5718  (Specifically 5647,5651,5652,5660,5657, 5664,  5654,5686,5687,5688,5689, 5606,  5690,5700,5701,5699,5704,5705,5707,5708,  5714, 5716, and 5718)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution.
  • 제품 설명
    Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; || Intended use: To deliver x-ray radiation for therapeutic treatment of cancer. || Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA; and Siemens Medical Solutions AG, Roentgenstrasse, Kemnath, Germany, and Siemens Medical Solutions AG, Henkestrasse, Erlangen, Germany
  • Manufacturer
    Siemens Medical Solutions USA, Inc., Concord, CA

Manufacturer

Siemens Medical Solutions USA, Inc., Concord, CA
  • 제조사 주소
    Siemens Medical Solutions USA, Inc., Concord, CA, 4040 Nelson Ave, Concord CA 94520-1200
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA