Events

Device Recall Philips Intellivue Central Station Software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems 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
    38400
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1182-2007
  • 사례 시작날짜
    2007-07-16
  • 사례 출판 날짜
    2007-09-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53538
  • 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
    Central Station Software - Product Code MHX
  • 원인
    Incorrect patient assignment: the information center will in most cases be associated with the "incorrect" patient. this occurs on both standalone and networked systems running fixed mode monitoring. (this does not occur on systems that run flex mode monitoring).
  • 조치
    Philips Medical Systems issued a letter notification dated July 2007 " Urgent Device Correction". Customers with networked information centers will be corrected through a database server. Stand-Alone units will have a software correction. Software version J.00.25 will correct the problem. Users are advised not to use th 12 Lead Analysis and Export Option in fixed or flex mode monitoring unitl the software correction is made.

Device

Device Recall Philips Intellivue Central Station Software
  • 모델명 / 제조번호(시리얼번호)
    Software versions: J.00.23 and J.00.24 (You can determine the application software release as follows: 1-Enter Service Mode through "All Controls" , "Service" 2-Under the "Other Services " menu item, click "Software Versions" 3-"Application" lists the application software version.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK
  • 제품 설명
    Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station || Models: M3145, M3150, M3154, M3155, M3169
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • 제조사 주소
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA