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U.S. Department of Health and Human Services

Class 2 Device Recall The Remote Antenna Cable used with Philips MX40 Monitors.

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  Class 2 Device Recall The Remote Antenna Cable used with Philips MX40 Monitors. see related information
Date Initiated by Firm August 23, 2019
Create Date September 19, 2019
Recall Status1 Terminated 3 on January 03, 2024
Recall Number Z-2547-2019
Recall Event ID 83679
510(K)Number K041741  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted
pair data cable bundle and is a component of the Philips Remote Antenna (PN
867151).

The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to extend the coverage area of a Core Access Point for the wireless Smart-hopping system.
Code Information All Remote Antennas (PN 867151) shipped since May 2019 with marked "CM" rated coax data cable. Serial Numbers: DK82001096 DK82000314 DK82000358 DK82000457 DK82000465 DK82000610 DK82000650 DK82000747 DK82000773 DK82000939 DK82001008 DK82001074 DK82001083 DK74900244 DK74900242 DK82000679 DK82000946 DK82000970 DK82000971 DK82000974 DK82001114 DK82001124 DK82001130 DK82001131 DK82001132 DK82001174 DK82001218 DK82001311 DK82101505 DK82101533 DK82101566 DK82101911 DK82102050 DK82102053 DK82102273 DK82000975 DK82000980 DK82000991 DK82000999 DK82001000 DK82001021 DK82001111 DK82001297 DK82001301 DK82001310 DK82101609 DK82101824 DK82101910 DK82102278 DK74900162 DK74900164 DK74900167 DK74900180 DK74900236 DK74900268 DK74900269 DK74900278 DK74900288 DK74900290 DK74900300 DK74900303 DK82000778 DK82000782 DK82000795 DK82000603 DK82000635 DK82000719 DK82000828 DK82000852 DK82000853 DK82000898 DK74900182 DK74900212 DK74900232 DK74900281 DK74900284 DK74900287 DK74900304 DK74900307 DK82000399 DK82000446 DK82000459 DK82000569 DK82000587 DK82000730 DK82000734 DK82000766 DK82000777 DK82000903 DK82000941 DK82000943 DK82000694 DK82000711 DK82000832 DK82000842 DK82000918 DK82000920 DK82000960 DK82000961 DK82001060 DK82001065 DK82001085 DK82001095 DK82001189 DK82001190 DK82001203 DK82001206 DK82001229 DK82001232 DK82001240 DK82001241 DK82000845 DK82000847 DK82000849 DK82000988 DK82001056 DK82001057 DK82001166 DK82001181 DK82001187 DK82001210 DK82001211 DK82001216 DK82001264 DK82001265 DK82001274 DK74900165 DK74900168 DK74900185 DK74900233 DK74900292 DK74900293 DK74900296 DK82000338 DK82000433 DK82000434 DK82000437 DK82000440 DK82000454 DK82000455 DK82000496 DK82000497 DK82000527 DK82000592 DK82000607 DK82000608 DK74900267 DK74900285 DK74900291 DK82000339 DK82000417 DK82000422 DK82000441 DK82000444 DK82000447 DK82000515 DK82000516 DK82000517 DK82000612 DK82000678 DK82103352 DK82101389 DK82101402 DK82101412 DK82101547 DK82102884 DK82102888 DK82102905 DK82103224 DK82102177 DK82102563 DK82102776 DK82103297 DK82000316 DK82000317 DK82000891 DK82000906 DK82000958 DK82001079 DK82001177 DK82001201 DK82101564 DK82101574 DK82102311 DK82102828 DK82102467 DK82102559 DK82102662 DK82000600 DK82102883 DK82102507 DK82102573 DK82102659 DK82102858 DK82000336 DK82000791 DK82000793 DK82000798 DK82000799 DK82000675 DK82000784 DK82000790 DK82102214 DK82101363 DK82101612 DK82101646 DK82101677 DK82101756 DK82101791 DK82101805 DK82101823 DK82101903 DK82102086 DK82102088 DK82102113 DK82101619 DK82000805 DK82102106 DK82102276 DK82102297 DK82102471 DK82102485 DK82102504 DK82102505 DK82102558 DK82102578 DK82102615 DK82102617 DK82102621 DK82102622 DK82102525 DK82102526 DK82102527 DK82000337 DK82000445 DK82000611 DK82102189 DK82000400 DK82000430 DK82000693 DK82000697 DK82001281 DK82101975 DK82101990 DK82102003 DK82001247 DK82001250 DK82001277 DK82103234 DK82101591 DK82101825 DK82102055 DK82101503 DK82102777 DK82101958 DK82102583 DK82102587 DK82102608 DK82102635 DK82102949 DK82102910 DK82102921 DK82102930 DK82102931 DK82102947 DK82103221 DK82103333 DK82103336 DK82103337 DK82103354 DK82102264 DK82101472 DK82101709 DK82101778 DK82101483 DK82101817 DK82101493 DK74900243 DK82102207 DK82102270 DK82102417 DK82102454 DK82102491 DK82102860 DK82102869 DK82102920 DK82102925 DK82102945 DK82102948 DK82103107 DK82103116 DK82000753 DK82000861 DK82000353 DK82000367 DK82000379 DK82000721 DK82000924 DK82000808 DK82000606 DK82000783 DK82102274 DK82000851 DK82000860 DK82001308 DK82102853 DK82000745 DK82000752 DK82101907 DK82001097 DK82101397 DK82103288 DK82101465 DK82101947 DK82102006 DK82102012 DK82102595 DK82103136 DK82103211 DK82103216 DK82103219 DK82000582 DK82103325 DK82103302 DK82103254 DK82103197 DK82103135 DK82103132 DK82103102 DK82103074 DK82103009 DK82103008 DK82102908 DK82102846 DK82102796 DK82102734 DK82102723 DK82102653 DK82102652 DK82102649 DK82102643 DK82102629 DK82102571 DK82102542 DK82102506 DK82102429 DK82102394 DK82001091 DK82000632 DK82000662 DK82000938 DK82001078 DK82001090 DK82001051 DK82000373 DK82000409 DK82000656 DK82000658 DK82000661 DK82001053 DK82000645 DK82000652 DK82103001 DK82102940 DK82001088 DK82102444 DK82102235 DK82102215 DK74900245 DK74900175 DK74900241 DK82103160 DK82001135 DK82001298 DK82001299 DK82001305 DK82102584 DK82103087 DK82103122 DK82103123 DK82103137 DK82103145 DK82101682 DK82101509 DK82101526 DK82101683 DK82101623 DK82101679 DK82101943 DK82101984 DK82101988 DK82102019 DK82102172 DK82000360 DK82000554 DK82000562 DK82000571 DK82000802 DK82000877 DK82000935 DK82000984 DK82001094 DK82001118 DK82001128 DK82001162 DK82000714 DK82000722 DK82000757 DK82001005 DK82001044 DK82001050 DK82001184 DK82001192 DK82001198 DK82001233 DK82001238 DK82001239 DK82001266 DK82001286 DK82001215 DK82000735 DK82000807 DK82000972 DK82001016 DK82102348 DK82101527 DK82101706 DK82101982 DK82102310 DK82101354 DK82101358 DK82101399 DK82101450 DK82101535 DK82101686 DK82102027 DK82102035 DK82102046 DK82001287 DK82000341 DK82000354 DK82000364 DK82000512 DK82000513 DK82000586 DK82000700 DK82000701 DK82000705 DK82000709 DK82000772 DK82000797 DK82000826 DK82000827 DK82000834 DK82000835 DK82000836 DK82001075 DK82001093 DK82001167 DK82001168 DK82001169 DK82001183 DK82001221 DK82001235 DK82000665 DK82000666 DK82000668 DK82000674 DK82000681 DK82000684 DK82000685 DK82000765 DK82000768 DK82000771 DK82000780 DK82000781 DK82000787 DK82000850 DK82000858 DK82000863 DK82001001 DK82001033 DK82001186 DK82102099 DK82101379 DK82101403 DK82101404 DK82101422 DK82101442 DK82101451 DK82101468 DK82101521 DK82101580 DK82101590 DK82101604 DK82101607 DK82101614 DK82101618 DK82101680 DK82101693 DK82101697 DK82101700 DK82101704 DK82101799 DK82101800 DK82101809 DK82101841 DK82101848 DK82101852 DK82101858 DK82101873 DK82101922 DK82101926 DK82101927 DK82101992 DK82101993 DK82101997 DK82101999 DK82102034 DK82102051 DK82102057 DK82102112 DK82102115 DK82102138 DK82102141 DK82102147 DK82102149 DK82102243 DK82102255 DK82102256 DK82102261 DK82102266 DK82102277 DK82102281 DK82102289 DK82102293 DK82102299 DK82102306 DK82102309 DK82102315 DK82102335 DK82102337 DK82103049 DK82103147 DK82103177 DK82103227 DK82103264 DK82103266 DK82103267 DK82103268 DK82103269 DK82103272 DK82103273 DK82103295 DK82103310 DK82103329 DK82103358 DK82103378 DK82101419 DK82101426 DK82101427 DK82101429 DK82101431 DK82101482 DK82101507 DK82101514 DK82101518 DK82101597 DK82101859 DK82102025 DK82102121 DK82102216 DK82102226 DK82102227 DK82102257 DK82102265 DK82102324 DK82102345 DK82102398 DK82102403 DK82102422 DK82102441 DK82102446 DK82102465 DK82102560 DK82102620 DK82102623 DK82102628 DK82102670 DK82102683 DK82102728 DK82102732 DK82102790 DK82102837 DK82102859 DK82102868 DK82102876 DK82102889 DK82102899 DK82102965 DK82102137 DK82102139 DK82102142 DK82102196 DK82102239 DK82102240 DK82102245 DK82102250 DK82102253 DK82102456 DK82102461 DK82102462 DK82102470 DK82102657 DK82102720 DK82102780 DK82102875 DK82101901 DK82101902 DK82101908 DK82102886 DK82102900 DK82101511 DK82101522 DK82101532 DK82101539 DK82101549 DK82101576 DK82101583 DK82101657 DK82101691 DK82101703 DK82101708 DK82101725 DK82101731 DK82101757 DK82101764 DK82101843 DK82101857 DK82101893 DK82101925 DK82101963 DK82102098 DK82102934 DK82000653 DK82001028 DK82001030 DK82102400 DK82102406 DK82102407 DK82102426 DK82102445 DK82102658 DK82102664 DK82102682 DK82102689 DK82102694 DK82102716 DK82102727 DK82103260 DK82103247 DK82103249 DK82103198 DK82103222 DK82103233 DK82103242 DK82103075 DK82103090 DK82103166 DK82102935 DK82102984 DK82103019 DK82103065 DK82000893 DK82102469 DK82102625 DK82102663 DK82102737 DK82102788 DK82000N38 DK82000737 DK82000742 DK82000743 DK82000804 DK82000846 DK82000856 DK82000932 DK82000947 DK82000992 DK82000995 DK82001004 DK82001024 DK82001269 DK82000347 DK82000361 DK82000456 DK82000458 DK82000532 DK82000548 DK82000598 DK82000605 DK82000717 DK82104961 DK82102413 DK82102418 DK82102428 DK82102449 DK82102450 DK82102452 DK82102455 DK82102488 DK82102490 DK82102503 DK82102523 DK82102524 DK82102564 DK82102565 DK82102586 DK82102594 DK82102596 DK82102598 DK82102603 DK82102614 DK82102676 DK82102764 DK82102778 DK82102783 DK82102818 DK82102829 DK82102844 DK82102848 DK82102850 DK82102852 DK82102855 DK82102861 DK82102863 DK82102943 DK82102946 DK82102953 DK82102980 DK82102995 DK82103010 DK82103011 DK82103022 DK82103081 DK82103083 DK82103098 DK82103100 DK82103112 DK82103318 DK82103343 DK82103363 DK82103384 DK82103366 DK82103301 DK82102871 DK82102874 DK82102881 DK82102904 DK82103263 DK82103290 DK82103293 DK82102736 DK82001212 DK82102508 DK82102509 DK82102741 DK82000508 DK82001126 DK82001129 DK82101405 DK84103043 DK82102803 DK82102787 DK82102786 DK82102772 DK82102798 DK82102795 DK82102793 DK82102791 DK82102474 DK82102272 DK82102197 DK82103361 DK82102531 DK82102592 DK82102259 DK82102396 DK82102424 DK82102425 DK82102430 DK82102431 DK82102530 DK82102402 DK82103125 DK82103126 DK82103284 DK82103326 DK82103327 DK82103338 DK82103339 DK82103356 DK82000936 DK82000624 DK82102898 DK82102468 DK82102590 DK82102607 DK82102650 DK82102740 DK82000899 DK82000340 DK82000342 DK82000343 DK82000348 DK82000368 DK82000369 DK82000370 DK82000450 DK82000646 DK82000649 DK82000843 DK82001049 DK82102464 DK82102626 DK82102665 DK82102687 DK82102983 DK82103003 DK82102522 DK82102528 DK82102618 DK82102712 DK82102713 DK82102982 DK82103079 DK82103185 DK82103225 DK82102872 DK82102878 DK82102882 DK82001194 DK82001282 DK82102864 DK82000536 DK82000751 DK82000769 DK82000859 DK82000385 DK82000599 DK82000640 DK82001156 DK82001309 DK82102427 DK82102473 DK82000732 DK82000934 DK82001072 DK82102865 DK82103191 DK82102725 DK82102847 DK82102879 DK82000564 DK82101748 DK82102521 DK82102624 DK82102701 DK82103121 DK82103179 DK82103190 DK82102996 DK82102442 DK82102695 DK82103005 DK82102867 DK82103237 DK82000427 DK82103148 DK82102933 DK82102952 DK82102919 DK82000581 DK82101484 DK82103381 DK82103380 DK82103365 DK82103390 DK82103364 DK82103207 DK82103203 DK82103170 DK82103169 DK82102724 DK82102248 DK82102210 DK82102192 DK82102185 DK82102180 DK82102174 DK82102135 DK82102076 DK82101951 DK82101940 DK82101930 DK82101769 DK82101768 DK82101762 DK82101617 DK82101606 DK82101525 DK82101392 DK81101970 DK82103312 DK82101955 DK82102706 DK82102766 DK82103076 DK82103113 DK82103184 DK82103193 DK82103220 DK82103232 DK82103239 DK82103240 DK82103241 DK82103246 DK82103251 DK82103308 DK82103253 DK82103316 DK82103314 DK82101895 DK82101894 DK82101892 DK82101850 DK82101835 DK82101807 DK82101759 DK82101581 DK82101551 DK82101499 DK74900270 DK74900294 DK82000394 DK82000426 DK82000644 DK82000663 DK74900210 DK74900229 DK74900237 DK74900252 DK74900258 DK74900266 DK82103391 DK82000362 DK82000387 DK82000415 DK82000416 DK82000514 DK82000545 DK82000657 DK82000774 DK82000775 DK82000776 DK82000779 DK82000786 DK82000890 DK82000902 DK82000907 DK82001022 DK82001048 DK82001059 DK82001195 DK82001243 DK82101473 DK82101562 DK82101602 DK82101772 DK82101818 DK82101830 DK82101918 DK82102066 DK82102084 DK82102089 DK82102305 DK82102440 DK82102466 DK82102539 DK82102541 DK82102546 DK82102581 DK82102630 DK82102647 DK82102704 DK82102709 DK82102718 DK82102719 DK82102729 DK82102779 DK82102894 DK82103039 DK82103044 DK82103054 DK82103152 DK82103154 DK82103173 DK82103176 DK82103235 DK82103248 DK82103255 DK82103282 DK82103322 DK82103362 DK82103376 DK82000333 DK82000493 DK82000602 DK82000883 DK82000976 DK82001011 DK82001013 DK82001086 DK82001197 DK82001204 DK82001209 DK82001267 DK82001270 DK82102482 DK82102493 DK82102534 DK82102593 DK82102633 DK82102646 DK82102648 DK82102671 DK82102685 DK82102797 DK82102834 DK82102835 DK82102998 DK82103014 DK82103020 DK82103040 DK82103045 DK82103048 DK82103055 DK82103063 DK82103066 DK82103073 DK82103078 DK82103096 DK82103119 DK82103130 DK82103141 DK82103143 DK82103161 DK82103171 DK82103183 DK82103226 DK82103230 DK82103231 DK82103244 DK82103245 DK82103367 DK82103373 DK82102641 DK82102492 DK82001289 DK82000561 DK82000707 DK82000713 DK82000741 DK82000767 DK82001170 DK82102166 DK82101452 DK82101678 DK82102131 DK82102873 DK82102447 DK82102672 DK82102686 DK82102638 DK82102679 DK82101372 DK82101360 DK82101382 DK82101384 DK82101385 DK82101388 DK82101393 DK82101441 DK82101707 DK82101862 DK82101959 DK82101986 DK82102132 DK82102518 DK82102538 DK82102544 DK82102610 DK82102708 DK82102753 DK82103331 DK82103311 DK82103304 DK82102755 DK82102545 DK82102408 DK82103347 DK82103346 DK82103342 DK82103332 DK82103296 DK82103283 DK82103270 DK82102866 DK82102232 DK82102220 DK82102154 DK82102655 DK82102502 DK82103210 DK82000315 DK82102944 DK82102785 DK82000794 DK82102722 DK82102489 DK82000806 DK82000398 DK82000401 DK82000474 DK82000540 DK82000546 DK82000549 DK82000566 DK82000673 DK82000704 DK82000728 DK82000729 DK82102807 DK82102911 DK82102913 DK82001261 DK82101523 DK82101952 DK82101980 DK82102928 DK82102929 DK82102932 DK82001176 DK82001257 DK82001260 DK82000810 DK82000837 DK82000901 DK82000913 DK82000736 DK82000746 DK82001165 DK82000864 DK82102666 DK82102656 DK82102688 DK82102769 DK82102789 DK82102901 DK82000439 DK82000911 DK82101905 DK82102114 DK82102520 DK82102749 DK82101611 DK82101876 DK82102104 DK82101376 DK82101937 DK82102072 DK82000931 DK82000748 DK82103351 DK82101471 DK82101485 DK82101600 DK82102191 DK82102201 DK82102213 DK82102217 DK82102221 DK82102223 DK82102419 DK82102775 DK82103300 DK82103303 DK82103305 DK82103350 DK82103204 DK82103205 DK82103257 DK82103259 DK82103262 DK82103278 DK82103285 DK82103287 DK82103291 DK82103299 DK82102568 DK82000801 DK82000733 DK82000763 DK82101548 DK82102241 DK82001171 DK82000411 DK82000432 DK82000460 DK82001035 DK82001077 DK82103320 DK82102392 DK82102479 DK82102537 DK82102634 DK82102674 DK82102836 DK82102885 DK82102906 DK82102907 DK82102909 DK82102912 DK82102924 DK82102938 DK82102941 DK82103013 DK82103077 DK82103105 DK82103114 DK82103117 DK82103199 DK82103208 DK82103209 DK82103214 DK82103215 DK82103218 DK82103252 DK82103256 DK82103258 DK82103344 DK82103355 DK82103321 DK82103324 DK82103330 DK82103261 DK82103280 DK82103289 DK82101941 DK84101983 DK82102340 DK82102229 DK82102200 DK82102198 DK82102190 DK82102183 DK82102176 DK82102175 DK82102102 DK82102033 DK82102028 DK82102022 DK82102021 DK82102013 DK82102011 DK82102010 DK82102009 DK82101998 DK82101973 DK82101972 DK82101944 DK82101705 DK82101701 DK82101695 DK82101694 DK82101608 DK82101588 DK82101560 DK82101559 DK82101558 DK82101492 DK82101474 DK82101469 DK82101456 DK82101423 DK82101416 DK82101386 DK82101356 DK82000973 DK82000989 DK82001117 DK82001228 DK82001256 DK82102782 DK82102460 DK82102510 DK82102678 DK82108816 DK82101755 DK82101438 DK82101659 DK82103187 DK74900271 DK82000322 DK82000491 DK82000501 DK82000558 DK82000563 DK82000575 DK82000621 DK82000655 DK82000686 DK82000687 DK82000690 DK82000691 DK82000695 DK82000699 DK82000708 DK82000710 DK82000754 DK82000760 DK82000758 DK82000761 DK82000840 DK82000895 DK82001068 DK82001069 DK82001193 DK82101587 DK82101653 DK82101996 DK82102101 DK82102472 DK82102627 DK82103064 DK82102333 DK82102218 DK82102231 DK82102233 DK82102242 DK82102260 DK82102319 DK82102326 DK82102332 DK82103243 DK82103118 DK82103228 DK82103158 DK82102991 DK82103120 DK82103162 DK82103167 DK8210317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Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact SAME
978-659-3000
Manufacturer Reason
for Recall		 Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
FDA Determined
Cause 2		 Process control
Action Philips issued customer notification on 08/19/2019 and delivering on 08/23/2019 via priority mail. Letter states reason for recall, health risk and action to take: Customers with affected cables installed need not take any immediate action. The cables subject to this recall do not affect the normal operation of MX4O System with Smart Hopping Infrastructure. Philips Healthcare will contact you to schedule a service team to replace affected cables. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800- SUPPORT 722-9377.
Quantity in Commerce 1790 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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