Device Recall Central Station Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems, Inc. Cardiac & Monitoring 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
    25430
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0594-03
  • 사례 시작날짜
    2003-01-02
  • 사례 출판 날짜
    2003-02-28
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2006-02-15
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    Central station monitoring information centers may experience sreeen freeze, i.E. loss of display, keyboard or mouse lock up.
  • 조치
    Philips Medical Systems notified users by Certified Mail on/about 2/19/03 that the firm was initiating a device field correction (recall) to conduct an upgrade to units witha HP VL400 or VL420 computer which is cconfigured for dual display by replacing the video and network communication card. Previous to this notification, Philips sent letters on 1/2/03 addressed to Biomedical Engineering Manager to advise users to reboot the system in the event of a system freeze.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial Serial 4102A02856 4102A10464 4102A10465 4102A10466 4102A10467 4102A10468 4102A10470 4102A10473 4102A10483 4102A10488 4102A10491 4102A10492 4102A10498 4102A10499 4102A10506 4102A10509 4102A10520 4102A10523 4102A10524 4102A10525 4102A10526 4102A10527 4102A10531 4102A10534 4102A10535 4102A10536 4102A10537 4102A10539 4102A10540 4102A10546 4102A10549 4102A10550 4102A10554 4102A10555 4102A10556 4102A10557 4102A10558 4102A10567 4102A10568 4102A10573 4102A10574 4102A10576 4102A10578 4102A10587 4102A10589 4102A10591 4102A10597 4102A10599 4102A10624 4102A10625 4102A10628 4102A10633 4102A10634 4102A10637 4102A10653 4102A10656 4102A10659 4102A10660 4102A10662 4102A10663 4102A10664 4102A10679 4102A10688 4102A10689 4102A10692 4102A10695 4102A10707 4102A10709 4102A10710 4102A10712 4102A10721 4102A10723 4102A10726 4102A10727 4102A10728 4102A10729 4102A10730 4102A10731 4102A10732 4102A10738 4102A10743 4102A10744 4102A10746 4102A10749 4102A10752 4102A10753 4102A10756 4102A10757 4102A10758 4102A10759 4102A10760 4102A10766 4102A10768 4102A10769 4102A10771 4102A10774 4102A10775 4102A10777 4102A10780 4102A10781 4102A10782 4102A10793 4102A10818 4102A10821 4102A10825 4102A10827 4102A10828 4102A10854 4102A10858 4102A10862 4102A10863 4102A10864 4102A10874 4102A10875 4102A10876 4102A10890 4102A10893 4102A10900 4102A10901 4102A10908 4102A10909 4102A10910 4102A10911 4102A10926 4102A10928 4102A10931 4102A10933 4102A10934 4102A10936 4102A10942 4102A10943 4102A10954 4102A10957 4102A10960 4102A10966 4102A10967 4102A10968 4102A10970 4102A10972 4102A10974 4102A10981 4102A10982 4102A11000 4102A11003 4102A11004 4102A11008 4102A11009 4102A11010 4102A11014 4102A11018 4102A11019 4102A11023 4102A11030 4102A11031 4102A11039 4102A11042 4102A11043 4102A11053 4102A11054 4102A11058 4102A11059 4102A11060 4102A11061 4102A11063 4102A11067 4102A11072 4102A11073 4102A11079 4102A11081 4102A11082 4102A11083 4102A11084 4102A11086 4102A11103 4102A11106 4102A11108 4102A11122 4102A11125 4102A11125 4102A11126 4102A11126 4102A11127 4102A11146 4102A11147 4102A11148 4102A11154 4102A11158 4102A11172 4102A11173 4102A11174 4102A11175 4102A11176 4102A11182 4102A11183 4102A11184 4102A11186 4102A11189 4102A11194 4102A11195 4102A11196 4102A11208 4102A11214 4102A11215 4102A11216 4102A11217 4102A11227 4102A11233 4102A11236 4102A11237 4102A11247 4102A11248 4102A11249 4102A11253 4102A11256 4102A11257 4102A11258 4102A11259 4102A11260 4102A11262 4102A11263 4102A11264 4102A11265 4102A11266 4102A11268 4102A11269 4102A11270 4102A11271 4102A11274 4102A11278 4102A11282 4102A11283 4102A11288 4102A11302 4102A11303 4102A11305 4102A11306 4102A11307 4102A11308 4102A11314 4102A11315 4102A11327 4102A11330 4102A11334 4102A11336 4102A11336 4102A11337 4102A11338 4102A11348 4102A11349 4102A11350 4102A11351 4102A11352 4102A11353 4102A11356 4102A11357 4102A11359 4102A11363 4102A11371 4102A11382 4102A11386 4102A11387 4102A11388 4102A11397 4102A11398 4102A11399 4102A11400 4102A11404 4102A11405 4102A11411 4102A11412 4102A11413 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  • 의료기기 분류등급
  • 유통
    Nationwide Canada, Europe, Asia, Latin America
  • 제품 설명
    Viridia/Agilent Information Center || Model : || M3150A#C01
  • Manufacturer

Manufacturer

  • 제조사 주소
    Philips Medical Systems, Inc. Cardiac & Monitoring Systems, 3000 Minuteman Road, Andover MA 01810
  • Source
    USFDA