FDAFDA · Alimentos y medicamentos·N.º oficial Z-0034-2018
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Publicado el 25 de octubre de 2017 · Inicio del retiro: 28 de agosto de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- St Jude Medical Inc.
- Distribuidor
- Worldwide Distribution
- Lote
- Serial Numbers: 2678856 2678867 2678859 2678857 2678877 2678872 2678870 2678869 2683929 2678863 2678858 2678866 2678878 2678868 2678860 2678874 2678879 2678864 2683921 2673458 2683918 2683917 2683914 2683928 2683927 2678862 2683922 2678880 2683920 2683930 2683911 2683916 2675733 2678861 2678871 2683923 2673452 2678876 2675748 2675747 2675742 2675737 2675731 2675743 2673467 2675739 2673449 2673448 2673457 2673459 2673469 2673468 2673466 2673465 2675727 2683924 2678865 2675734 2675728 2675725 2675736 2675745 2675740 2678875 2675732 2675730 2675749 2675746 2675738 2675729 2675735 2675726 2692492 2689903 2691326 2691327 2691328 2691334 2691330 2683919 2689905 2691332 2692495 2692497 2692483 2692488 2692489 2692490 2691329 2689901 2678873 2689899 2689908 2689906 2689907 2689897 2691325 2689900 2691333 2689898 2689909 2689904 2689902 2689896 2691331 2692481 2689910 2686717 2692491 2686730 2686728 2686722 2686721 2686726 2686712 2686718 2686723 2686720 2686715 2683913 2683915 2683926 2683912 2683925 2686725 2692485 2675741 2692482 2692499 2692500 2692493 2692494 2686714 2692484 2692487 2686729 2686719 2686716 2686711 2686713 2686727 2686724 2692496 2697416 2697406 2697407 2697411 2697415 2697401 2697403 2697408 2697405 2697413 2697414 2697412 2697409 2697410 2697419 2697400 2613924 2697404 2613921 2613928 2617417 2613927 2613937 2613925 2613943 2697417 2613926 2699066 2613920 2613919 2673464 2613917 2675744 2692486 2692498 2613923 2699063 2697402 2700386 2700385 2699072 2700388 2699069 2700394 2699065 2700389 2699060 2699059 2699058 2699055 2697418 2699057 2699061 2699073 2700382 2699062 2699056 2699067 2699071 2699068 2699074 2700392 2699070 2613918 2700384 2700387 2700393 2700390 2700381 2700380 2700383 2699064 2646730 2613916 2646718 2613930 2646736 2646735 2646734 2645827 2646731 2646728 2646727 2646726 2646725 2646723 2646722 2646721 2646732 2673454 2673463 2673462 2673461 2673460 2673456 2673447 2646719 2673455 2646733 2673453 2673451 2673450 2673445 2646724 2646729 2646737 2673446 2613938 2613929 2613944 2617416 2613932 2613945 2613941 2645808 2613939 2613936 2645826 2613935 2646720 2613933 2613922 2613931 2613940 2645822 2613934 2645809 2645825 2645823 2645821 2645820 2645819 2645818 2645817 2645812 2645810 2645824 2645811 2645816 2645814 2645815 2645813 3004783 3004782 3004780 3004779 3003113 3004781 3003111 3057612 3061676 3003112 3003110 3003109 3057616 3065294 3065289 3061677 3065287 3061675 3061678 3057614 3065295 2847869 3057615 3057613 3061674 2847868 2971148 2958000 3065291 2971146 2971149 2996824 2976064 3096830 3096828 3096826 3096827 2847872 2847875 3096829 2847870 2971153 2847874 3085187 3084071 3084069 3085185 3084070 3090092 3090093 3084068 2971151 3084072 3083191 2958004 2957999 2958002 2957997 2957995 2958003 3095477 3095475 3095479 3095476 3095478 2957998 3083189 2957996 3083192 3083193 3065292 3065290 3065286 3065293 3085183 3085186 3090497 2971150 2971145 3090496 2941096 2941098 2941088 2941086 2941087 2941091 2941092 2941093 2941099 2941097 2941090 2941100 2958001 2941095 3085184 2941089 2943232 2943233 2943234 2943235 2943231 2948921 2948922 2948923 2948919 2948920 2941094 2997964 2835430 2835422 2994720 2994721 2997963 2994718 2835428 2835425 2997967 2997966 2996828 2835424 2835429 2994717 2994719 2720440 2716838 2996826 2276862 2971154 3002165 3002164 3002162 3002169 2997965 2716833 2977854 2977856 2725067 2977857 2741101 2741098 2741104 2741099 2741102 2741097 2741095 2835427 2716831 2716835 2716836 2741096 2835426 3001457 2977853 2977855 2725064 2725071 2834077 28354
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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