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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0853-2019

PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Publicado el 27 de febrero de 2019 · Inicio del retiro: 9 de enero de 2019

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Philips North America, LLC
Distribuidor
Domestic distribution nationwide. Foreign distribution worldwide.
Lote
CN80811000 CN80811001 F5N7000106 F5N7000107 F5O7000002 F5O7000024 F5O7000027 F5O7000037 F5O7000078 F5O7000085 F5O7000091 F5O7000093 US10901771 US10901772 US10901773 US10901774 US10901775 US10901776 US10901777 US10901778 US10901779 US10901782 US10901783 US10901784 US10901785 US10901786 US10901787 US10901788 US10901789 US10901790 US10901791 US10901792 US10901793 US10901794 US10901795 US10901796 US10901797 US10901798 US10901799 US10901800 US10901801 US10901802 US10901803 US10901804 US10901805 US10901806 US10901807 US10901808 US10901809 US10901810 US10901811 US10901812 US10901813 US10901814 US10901815 US10901816 US10901817 US10901818 US10901819 US10901821 US10901822 US10901823 US10901824 US10901825 US10901826 US10901829 US10901830 US10901831 US10901832 US10901833 US10901834 US10901835 US10901836 US10901837 US10901838 US10901839 US10901840 US10901841 US10901842 US10901843 US10901844 US10901845 US10901846 US10901847 US10901848 US10901850 US10901851 US10901852 US10901853 US10901854 US10901855 US10901856 US10901857 US10901858 US10901859 US10901860 US10901861 US10901862 US10901863 US10901864 US10901865 US10901866 US10901867 US10901868 US10901869 US10901870 US10901871 US10901872 US10901873 US10901874 US10901887 US10901888 US10901889 US10901890 US10901891 US10901892 US10901893 US10901894 US10901895 US10901896 US10901897 US10901898 US10901899 US10901900 US10901901 US10901902 US10901907 US10901908 US10901909 US10901910 US10901911 US10901912 US10901913 US10901914 US10901915 US10901916 US10901917 US10901918 US10901919 US10901920 US10901921 US10901922 US10901923 US10901924 US10901925 US10901926 US10901927 US10901928 US10901929 US10901930 US10901931 US10901932 US10901933 US10901934 US10901938 US10901939 US10901940 US10901941 US10901942 US10901943 US10901944 US10901945 US10901946 US10901947 US10901948 US10901949 US10901950 US10901951 US10901952 US10901953 US10901954 US10901955 US10901956 US10901957 US10901958 US10901959 US10901960 US10901961 US10901962 US10901963 US10901964 US10901965 US10901966 US10901967 US10901968 US10901969 US10901970 US10901971 US10901972 US10901973 US10901974 US10901975 US10901976 US10901977 US10901978 US10901979 US10901980 US10901981 US10901982 US10901983 US10901984 US10901985 US10901986 US10901987 US10901988 US10901989 US10901990 US10901991 US10901992 US10901993 US10901994 US10901995 US10901996 US10901997 US10901998 US10901999 US10902000 US10902001 US10902002 US10902003 US10902004 US10902005 US10902006 US10902007 US10902008 US10902009 US10902010 US11003987 US11003988 US11003989 US11003990 US11003991 US11003992 US11003993 US11003994 US11003995 US11003996 US11003997 US11003998 US11003999 US11004000 US11004001 US11004002 US11004003 US11004004 US11004005 US11004006 US11004007 US11004008 US11004009 US11004010 US11004011 US11004012 US11004013 US11004014 US11004015 US11004016 US11004017 US11004018 US11004019 US11004020 US11004021 US11004022 US11004024 US11004025 US11004026 US11004027 US11004028 US11004029 US11004030 US11004031 US11004032 US11004033 US11004034 US11004035 US11004036 US11004037 US11004038 US11004039 US11004040 US11004041 US11004042 US11004043 US11004044 US11004045 US11004046 US11004047 US11004048 US11004049 US11004050 US11004051 US11004052 US11004053 US11004054 US11004055 US11004056 US11004057 US11004058 US11004059 US11004060 US11004061 US11004062 US11004063 US11004064 US11004065 US11004066 US11004068 US11004069 US11004070 US11004071 US11004072 US11004073 US11004074 US11004075 US11004076 US11004077 US11004078 US11004079 US11004080 US11004081 US11004082 US11004083 US11004084 US11004085 US11004086 US11004087 US11004088 US11004089 US11004090 US11004091 US11004092 US11004093 US11004094 US11
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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