Events

Device Recall LANTIS Commander 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
    58441
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2151-2011
  • 사례 시작날짜
    2011-03-23
  • 사례 출판 날짜
    2011-05-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99351
  • 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
    Device, digital image storage, radiological - Product Code LMB
  • 원인
    There is a potential safety issue in regard to data transfer between lantis ois system and the hospital information system (his) when the hl7 (adt) interfact is used.
  • 조치
    Siemens sent an Urgent Medical Device Correction letter on March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their LANTIS owner manual and contact there Siemens Service Engineer or Application Specialist or contact Lantis4.healthcare@siemens.com. For questions regarding this recall 925-602-8157.

Device

Device Recall LANTIS Commander
  • 모델명 / 제조번호(시리얼번호)
    Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS 6.1 Complete 8147527 LANTIS 6.1 Essential 8147535 LANTIS 8.3 Complete 8147543 LANTIS 8.3 Essential 8147550 LANTIS 8.3 Commander 8148178
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. || Distributed by Siemens, Concord, CA || Mfg by Impac Medical Systems, Sunnyvale, CA || Electronic patient records management system
  • 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