Events

Recall of Device Recall Central Station Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems, Inc. Cardiac & Monitoring Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25430
  • Event Risk Class
    Class 2
  • Event Number
    Z-0594-03
  • Event Initiated Date
    2003-01-02
  • Event Date Posted
    2003-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25818
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Central station monitoring information centers may experience sreeen freeze, i.E. loss of display, keyboard or mouse lock up.
  • Action
    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
  • Model / Serial
    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 4102A11413 4102A11416 4102A11422 4102A11424 4102A11429 4102A11430 4102A11433 4102A11436 4102A11451 4102A11453 4102A11454 4102A11456 4102A11458 4102A11463 4102A11467 4102A11471 4102A11472 4102A11473 4102A11481 4102A11482 4102A11493 4102A11495 4102A11496 4102A11500 4102A11501 4102A11507 4102A11511 4102A11516 4102A11517 4102A11518 4102A11520 4102A11530 4102A11531 4102A11532 4102A11536 4102A11537 4102A11543 4102A11544 4102A11545 4102A11549 4102A11552 4102A11561 4102A11562 4102A11564 4102A11565 4102A11566 4102A11567 4102A11568 4102A11569 4102A11576 4102A11577 4102A11578 4102A11579 4102A11588 4102A11590 4102A11591 4102A11592 4102A11593 4102A11595 4102A11598 4102A11600 4102A11606 4102A11607 4102A11608 4102A11613 4102A11614 4102A11618 4102A11619 4102A11631 4102A11632 4126A11603 4126A11604 4126A11624 4126A11625 4126A11629 4126A11633 4126A11639 4126A11642 4126A11645 4126A11663 4126A11664 4126A11666 4126A11667 4126A11668 4126A11670 4126A11676 4126A11677 4126A11680 4126A11681 4126A11682 4126A11693 4126A11694 4126A11700 4126A11701 4126A11703 4126A11719 4126A11721 4126A11727 4126A11728 4126A11729 4126A11731 4126A11733 4126A11735 4126A11740 4126A11741 4126A11742 4126A11757 4126A11758 4126A11759 4126A11760 4126A11765 4126A11771 4126A11772 4126A11773 4126A11774 4126A11775 4126A11776 4126A11777 4126A11778 4126A11784 4126A11798 4126A11800 4136A11801 4136A11802 4136A11804 4136A11805 4136A11806 4136A11807 4136A11808 4136A11809 4136A11810 4136A11814 4136A11815 4136A11817 4136A11818 4136A11818 4136A11821 4136A11823 4136A11824 4136A11825 4136A11826 4136A11827 4136A11851 4136A11854 4136A11855 4136A11856 4136A11863 4136A11864 4136A11865 4136A11866 4136A11867 4136A11868 4136A11869 4136A11871 4136A11872 4136A11873 4136A11874 4136A11879 4136A11880 4136A11881 4136A11885 4136A11886 4136A11887 4136A11888 4136A11889 4136A11890 4136A11891 4136A11893 4136A11896 4136A11902 4136A11908 4136A11909 4136A11919 4136A11932 4136A11938 4136A11939 4136A11941 4136A11942 4136A11943 4136A11944 4136A11947 4136A11948 4136A11949 4136A11958 4136A11959 4136A11960 4136A11962 4136A11963 4136A11964 4136A11970 4136A11971 4136A11973 4136A11974 4136A11975 4136A11980 4136A11989 4136A11990 4136A11991 4136A11992 4136A11993 4136A11996 4136A12005 4136A12007 4136A12008 4136A12009 4136A12015 4136A12016 4136A12017 4136A12023 4136A12024 4136A12026 4136A12027 4136A12028 4136A12029 4136A12034 4136A12035 4136A12036 4136A12037 4136A12044 4136A12057 4136A12065 4136A12066 4136A12067 4136A12068 4136A12069 4136A12070 4136A12090 4136A12096 4136A12097 4136A12099 4136A12100 4136A12101 4136A12103 4136A12104 4136A12105 4136A12107 4136A12109 4136A12110 4136A12111 4136A12112 4136A12124 4136A12125 4136A12126 4136A12128 4136A12133 4136A12134 4136A12139 4136A12140 4136A12143 4143A03606 4143A11919 4143A12153 4143A12158 4143A12159 4143A12164 4143A12167 4143A12169 4143A12190 4143A12191 4143A12192 4143A12193 4143A12195 4143A12197 4143A12200 4143A12204 4143A12218 4143A12219 4143A12223 4143A12230 4143A12231 4143A12246 4143A12249 4143A12254 4143A12258 4143A12266 4143A12267 4143A12271 4143A12272 4143A12274 4143A12275 4143A12276 4143A12277 4143A12281 4143A12287 4143A12288 4143A12293 4143A12294 4143A12316 4143A12323 4143A12332 4143A12342 4143A12351 4143A12355 4143A12356 4143A12366 4143A12377 4143A12379 4143A12383 4143A12384 4143A12385 4143A12388 4143A12389 4143A12390 4143A12392 4143A12393 4143A12394 4143A12395 4143A12396 4143A12397 4143A12398 4143A12402 4143A12421 4143A12422 4143A12427 4143A12428 4143A12436 4143A12439 4143A12446 4143A12447 4143A12460 4143A12469 4143A12472 4143A12473 4143A12491 4143A12492 4143A12493 4143A12498 4143A12501 4143A12504 4143A12515 4143A12516 4143A12532 4143A12537 4143A12549 4143A12550 4143A12554 4143A12555 4143A12559 4143A12560 4143A12561 4143A12562 4143A12563 4143A12571 4143A12573 4143A12576 4143A12579 4143A12580 4143A12583 4143A12584 4143A12593 4143A12594 4143A12595 4143A12596 4143A12597 4143A12598 4143A12602 4143A12609 4143A12614 4143A12626 4143A12628 4143A12633 4143A12637 4143A12638 4143A12646 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 4143A12930 4212A12809 4212A12810 4212A12811 4212A12916 4212A12917 4212A12918 4212A12919 4212A12923 4212A12931 4212A12935 4212A12937 4213A01418 4213A12875 4213A12948 4213A12949 4213A12951 4213A12954 4213A12956 4213A12961 4213A12964 4213A12965 4213A12968 4213A12973 4213A12975 4213A12976 4213A12991 4213A12992 4213A12994 4213A12995 4213A12996 4213A12997 4213A13000 4213A13001 4213A13002 4213A13008 4213A13015 4213A13023 4213A13046 4213A13048 4213A13049 4213A13051 4213A13052 4213A13057 4213A13063 4213A13064 4213A13065 4213A13080 4213A13081 4213A13086 4213A13087 4213A13097 4213A13098 4213A13099 4213A13104 4213A13105 4213A13106 4213A13107 4213A13109 4213A13110 4213A13111 4213A13112 4213A13123 4213A13130 4213A13131 4213A13132 4213A13136 4213A13137 4213A13145 4213A13148 4213A13153 4213A13154 4213A13155 4213A13168 4213A13169 4213A13171 4213A13180 4213A13182 4213A13185 4213A13186 4213A13187 4213A13188 4213A13191 4213A13198 4213A13215 4213A13216 4213A13222 4213A13225 4213A13226 4213A13229 4213A13230 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
  • Product Classification
    Cardiovascular Devices
  • Distribution
    Nationwide Canada, Europe, Asia, Latin America
  • Product Description
    Viridia/Agilent Information Center || Model : || M3150A#C01
  • Manufacturer
    Philips Medical Systems, Inc. Cardiac & Monitoring Systems

Manufacturer

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