Events

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
    United States
  • 사례 종료 날짜
    2006-02-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25818
  • 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

Device Recall Central Station Monitor
  • 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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4143A12647 4143A12648 4143A12649 4143A12650 4143A12651 4143A12652 4143A12653 4143A12654 4143A12657 4143A12658 4143A12659 4143A12660 4143A12676 4143A12682 4143A12683 4143A12684 4143A12685 4143A12694 4143A12695 4143A12699 4143A12701 4143A12702 4143A12704 4143A12708 4143A12709 4143A12711 4143A12712 4143A12722 4143A12728 4143A12730 4143A12731 4143A12732 4143A12735 4143A12736 4143A12738 4143A12739 4143A12740 4143A12743 4143A12746 4143A12749 4143A12750 4143A12751 4143A12752 4143A12756 4143A12758 4143A12761 4143A12762 4143A12763 4143A12764 4143A12765 4143A12768 4143A12769 4143A12772 4143A12773 4143A12774 4143A12775 4143A12776 4143A12778 4143A12780 4143A12781 4143A12783 4143A12784 4143A12792 4143A12802 4143A12803 4143A12806 4143A12807 4143A12808 4143A12813 4143A12815 4143A12816 4143A12824 4143A12827 4143A12839 4143A12843 4143A12857 4143A12858 4143A12864 4143A12867 4143A12868 4143A12871 4143A12876 4143A12877 4143A12885 4143A12886 4143A12896 4143A12897 4143A12898 4143A12907 4143A12913 4143A12922 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4213A13231 4213A13232 4213A13233 4213A13234 4213A13235 4213A13236 4213A13237 4213A13238 4213A13242 4213A13243 4213A13250 4213A13252 4213A13267 4213A13268 4213A13269 4213A13273 4213A13274 4213A13276 4213A13278 4213A13282 4213A13284 4213A13295 4213A13296 4213A13297 4213A13298 4213A13306 4213A13313 4213A13317 4213A13318 4213A13320 4213A13325 4213A13326 4213A13327 4213A13328 4213A13340 4213A13343 4213A13345 4213A13350 4213A13351 4213A13352 4213A13353 4213A13354 4213A13358 4213A13359 4213A13360 4213A13361 4213A13364 4213A13379 4213A13382 4213A13386 4213A13387 4213A13389 4213A13390 4213A13397 4213A13402 4213A13407 4213A13409 4213A13410 4213A13416 4213A13422 4213A13423 4213A13431 4213A13434 4213A13436 4213A13437 4213A13439 4213A13446 4213A13449 4213A13450 4213A13451 4213A13453 4213A13455 4213A13456 4213A13457 4213A13460 4213A13461 4213A13463 4213A13474 4213A13479 4213A13480 4213A13481 4213A13482 4213A13483 4213A13489 4213A13490 4213A13493 4213A13494 4213A13500 4213A13501 4213A13502 4213A13504 4213A13505 4213A13507 4213A13521 4213A13522 4213A13523 4213A13528 4213A13529 4213A13530 4213A13531 4213A13532 4213A13534 4213A13535 4213A13536 4213A13544 4213A13567 4213A13568 4213A13570 4213A13583 4213A13586 4213A13587 4213A13588 4213A13589 4213A13590 4213A13591 4213A13592 4213A13593 4213A13594 4213A13595 4213A13597 4213A13598 4213A13599 4213A13601 4213A13602 4213A13604 4213A13608 4213A13609 4213A13610 4213A13611 4213A13617 4213A13619 4213A13621 4213A13622 4213A13626 4213A13628 4213A13629 4213A13630 4213A13639 4213A13640 4213A13641 4213A13648 4213A13648 4213A13648 4213A13648 4213A13660 4213A13661 4213A13662 4213A13663 4213A13670 4213A13673 4213A13676 4213A13678 4213A13679 4213A13685 4213A13686 4213A13687 4213A13697 4213A13698 4213A13699 4213A13700 4213A13711 4213A13712 4213A13714
  • 의료기기 분류등급
    Cardiovascular Devices
  • 유통
    Nationwide Canada, Europe, Asia, Latin America
  • 제품 설명
    Viridia/Agilent Information Center || Model : || M3150A#C01
  • Manufacturer
    Philips Medical Systems, Inc. Cardiac & Monitoring Systems

Manufacturer

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