Events

Device Recall ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist 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
    62519
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2073-2012
  • 사례 시작날짜
    2012-06-25
  • 사례 출판 날짜
    2012-07-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110823
  • 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
    Potential safety issue when using the immediate resumption feature after a control console interlock during the delivery of flattening-filter-free (multiple-x) beams or segments. in a very rare scenario, the rt therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered monitor units of the same beam or segment.
  • 조치
    The firm issued "Urgent: Medical Device Correction" letters delivered by the Siemens Customer Service Group or by certified mail to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm stated that release of this UI TH018/12/S to distribute the notifications began on June 25, 2012.

Device

Device Recall ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist
  • 모델명 / 제조번호(시리얼번호)
    ARTISTE, Part #: 08139789, ONCOR Avant Garde, Part #: 05863472, ONCOR Impression Plus, Part #: 05857912, ONCOR Expression, Part #: 07360717
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.
  • 제품 설명
    ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used 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, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA