Events

Device Recall IMPAC / Elekta Medicals Sequencer 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
    59347
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2983-2011
  • 사례 시작날짜
    2011-06-30
  • 사례 출판 날짜
    2011-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102338
  • 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
    Digital Image Storage System, Radiological - Product Code LMB
  • 원인
    A potential safety issue exists for data transfer between lantis ois system (containing primeview or primeview data gateway) and the sequencer v&r; system via a third party interface is used.
  • 조치
    Siemens sent an "Update Instructions/Customer Safety Advisory Notice" to all affected users, beginning June 30, 2011. The letter includes description of the product and problem and provides updated instructions to ensure data is stored in the system. If you have questions contact Siemens at (925) 602-8157.

Device

Device Recall IMPAC / Elekta Medicals Sequencer
  • 모델명 / 제조번호(시리얼번호)
    LANTIS Commander. Part Number 4503178; LANTIS system, Part Number 5835991; LANTIS 6.1 Commander, Part Number 5493072; LANTIS 8.3 Commander, Part Number 8148178  Linac Interface, other vendors: Part Number 4504994; LANTIS Varian Clinac, Part Number 1929251; LANTIS GE Saturn, Part Number: 1929277; LANTIS Philips SLS, Part Number 4507203; LANTIS Philips 75 ASU, Part Number 5494120; LANTIC Elekta (Philips), Part Number 5502880; LANTIS Varian EX I/F, Part Number 5846220.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Nationwide (USA) including the states of MI, DE, WI, FL, CA, TN, NJ, PA, NE, IL, WV , MA and VA; and the countries of Poland, France, Germany, Canada, Netherlands, India, Ireland, Egypt, P.R. china, Australia, Saudi Arabia, Turkey, Republic Korea, Belgium, Hungary, New Zealand, Italy, Malaysia, and Spain.
  • 제품 설명
    LANTIS Oncology Information System (OIS) || Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens. || An oncology digital imaging information management system. Lantis OIS in combination with Sequencer and a non-Siemens linac interface. || System components include: LANTIS Commander, LANTIS system, LANTIS 6.1 Commander, LANTIS 8.3 Commander. || Subcomponents include: Linac Interface, other vendor, LANTIS Varian Clinac, LANTIS GE Saturn, LANTIS Philips SLS, || LANTIS Philips 75 ASU, LANTIS Elekta (Philips) and LANTIS Varian EX I/F.
  • 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