Device Recall 550 TxT Treatment Tables which are used in PRIMUS, ONCOR, ARTISTE 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
    67126
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0787-2014
  • 사례 시작날짜
    2013-12-05
  • 사례 출판 날짜
    2014-01-17
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-01-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • 원인
    Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 txt treatment table. combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the txt" treatment table has been damaged due to contacting a moving part. the resulting short-circuit cau.
  • 조치
    The firm, Siemens, sent a "Medical Device Correction" letter to affected users/customers starting on December 5, 2013 via Federal express. The letter described the product, problem and actions to be taken. Siemens has arranged for modification of the affected 500 TxT Treatment Table. A service representative will modify the mounts of the TT-A, TT-D, TT-M, or TT-s table tops ( Pleases note that this modification only applies to the Siemens provided table tops TT-A, TT-D, TT-M, and TT-S.). In addition, the Siemens service representative will modify the cable routing inside of the patient table base. The customers were instructed to include this Field Safety Notice in your Digital Linear Accelerator System Owner manual chapter 'Safety Advisory Letters' where it should remain. If you have any questions, please contact the Senior Manager, Regulatory Affairs at 1-925-293-5442 or email: christine.dunbar@siemens.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    550 TxT table - part number 07346534.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and internationally to: Canada, Italy, P.R. China, Argentina, Pakistan, South Africa, Egypt, Iran, Vietnam, Indonesia, Brazil, Hungary, Bulgaria, India, Spain, Switzerland, Trinidad, Tobago, Italy, Algeria, Croatia, Turkey, Japan, Germany, Portugal, Poland, France, Sri Lanka, Russian Federation, France, Lebanon, Slovakia, Ukraine, Pakistan, and Korean Republic.
  • 제품 설명
    PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. || TT-A, TT-D, TT-M or TT-S Table tops. || Manufactured by: || SIEMENS AG, MEDICAL SOLUTIONS || Roentgenstrasse 19-21 || Kemnath, GERMANY 95478 || The intended use of the SIEMENS branded, 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

Manufacturer

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