FDAFDA · Food and drugs·Recall number Z-1923-2019
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Published July 17, 2019 · Recall initiated: June 7, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America, LLC
- Distributor
- Nationwide domestic distribution. Worldwide distribution.
- Lot
- Serial numbers: US00321116 US00205647 US00205648 US00554104 US00554105 US00554106 US00559530 US00559531 US00559532 US00559533 US00559534 US00559535 US00559536 US00559537 US00559538 US00559539 US00321076 US00321222 US00322701 US00544495 US00320900 US00580288 US00580298 US00580334 US00580335 US00580336 US00580337 US00580338 US00582916 US00582917 US00582918 US00582919 US00582920 US00582921 US00582922 US00582923 US00582924 US00582925 US00582926 US00582927 US00582928 US00582929 US00582930 US00582931 US00582932 US00582933 US00582934 US00582935 US00582936 US00582937 US00582938 US00582939 US00582940 US00582941 US00582942 US00582943 US00582944 US00582945 US00582946 US00582947 US00582948 US00582949 US00582950 US00582951 US00582952 US00582953 US00582954 US00582955 US00582956 US00582957 US00582958 US00582959 US00582960 US00582961 US00582962 US00582963 US00582964 US00582965 US00582966 US00582967 US00582968 US00582969 US00582970 US00582971 US00582972 US00582973 US00582974 US00582975 US00585293 US00585294 US00585295 US00585296 US00585297 US00585298 US00585299 US00585300 US00585301 US00585304 US00585305 US00585306 US00585307 US00585308 US00585309 US00586483 US00586484 US00586485 US00586486 US00586487 US00586488 US00586489 US00586490 US00586491 US00586492 US00589735 US00595040 US00600754 US00600755 US00600756 US00600757 US00600758 US00600759 US00600760 US00600761 US00600762 US00600763 US00600764 US00600765 US00600766 US00600767 US00600768 US00600770 US00600771 US00600772 US00600773 US00600774 US00600775 US00600776 US00600777 US00600778 US00600779 US00600780 US00600781 US00600782 US00600783 US00600784 US00600807 US00600808 US00600809 US00600810 US00600811 US00600812 US00600813 US00600814 US00600815 US00600816 US00600817 US00600818 US00600819 US00600820 US00600821 US00600822 US00600823 US00600824 US00600825 US00600826 US00600844 US00600845 US00600846 US00600847 US00600848 US00600849 US00600850 US00600851 US00600852 US00600853 US00600854 US00600855 US00600856 US00600857 US00600858 US00600859 US00600860 US00600861 US00600862 US00600863 US00600864 US00600865 US00600866 US00600867 US00600868 US00600869 US00600870 US00600871 US00600872 US00600873 US00600884 US00600885 US00600886 US00600887 US00600888 US00600889 US00600890 US00600891 US00600892 US00600893 US00600894 US00600895 US00600896 US00600897 US00600898 US00600899 US00600900 US00600901 US00600902 US00600903 US00600904 US00600905 US00600906 US00600907 US00600908 US00600909 US00600910 US00600911 US00600912 US00600913 US00600914 US00600915 US00600916 US00600917 US00600918 US00600919 US00600920 US00600921 US00600922 US00600923 US00600924 US00600925 US00600926 US00600927 US00600928 US00600929 US00600930 US00600931 US00600932 US00600933 US00600934 US00600935 US00600936 US00600937 US00600938 US00600939 US00600940 US00600941 US00600942 US00600943 US00600944 US00600945 US00600946 US00600947 US00600948 US00600949 US00600950 US00600951 US00600952 US00600953 US00602257 US00602258 US00602259 US00546151 US00546152 US00548068 US00548069 US00548070 US00548071 US00548072 US00548073 US00548074 US00548075 US00548076 US00548077 US00548078 US00548079 US00548080 US00548081 US00548082 US00548083 US00548084 US00548085 US00548086 US00548087 US00548088 US00548089 US00548090 US00548091 US00548092 US00550702 US00550703 US00550704 US00550705 US00550706 US00550707 US00550708 US00550709 US00550710 US00550711 US00552521 US00552522 US00552523 US00561587 US00561588 US00561589 US00561590 US00561591 US00561592 US00561593 US00561594 US00561595 US00561596 US00561597 US00561598 US00561599 US00561600 US00561601 US00561602 US00561603 US00561604 US00561605 US00561606 US00561607 US00561608 US00561609 US00561610
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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