Events

Device Recall ARTISTE , ONCOR and PRIMUS accelerators 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
    58534
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2216-2011
  • 사례 시작날짜
    2011-03-31
  • 사례 출판 날짜
    2011-05-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99531
  • 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
    Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the artiste linac rt therapist v4.2 in combination with rt oncologist v.4.2 and use the remote "online 2d image review.
  • 조치
    The firm, Siemens, sent an "Urgent: Medical Device Correction Customer Safety Advisory Notice" on March 31, 2011 via Siemens Customer Service Group or certified mail to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to not use the "Online 2D Image Review" on the Syngo RT Oncologist 4.2; to always calculate the offset directly on the RTT 4.2 before it is applied for the treatment with the patient on the treatment table; include this notice in their syngo RT Therapist 4.2 System Owner Manual chapter "Safety Advisory Letter" where it should remain until the measures defined in the notice are performed, and in the interest of safety, perform the preventative measures noted in this notice and inform all affected personnel immediately. Siemens is currently working on a solution for the incremental loading workflow in syngo RT Therapist 4.2 and will provide a software update as soon as possible. Siemens will notify the customers as soon as an update for their system will be available. UPDATE: The release of Safety Update UI TH010/11/S to distribute the software update for RTTv4.2.94O04 began on April 15, 2011. If you have any questions, contact Regulatory Affairs at 925-602-8157.

Device

Device Recall ARTISTE , ONCOR and PRIMUS accelerators
  • 모델명 / 제조번호(시리얼번호)
    Therapist Exoress Basis Part number 08515289 syngo Therapist Express Part Number 08162815 syngo RT Therapist Connect/ MOSAIQ OIS Part number 08168754.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: CA, FL, OH, PA and UT; and countries including: Australia, Belgium, Croatia, Germany, Japan, South Africa, Sweden and United Kingdom.
  • 제품 설명
    ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. || The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. || Distributed by Siemens Healthcare, Concord, CA 94520 || Intended use: Radiation therapy
  • 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