Hamilton Medical, Inc.: Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator

Hazard

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

Details from the source

Reason for recall: Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation. Distribution: Distribution US nationwide, including Puerto Rico. OUS: Not provided Quantity: 1216 units Lot/code info: UDI: 07630002806091 & 07630002813549 / Affected Serial Numbers: 500816 501879 502181 502200 502587 502588 502589 502591 502647 502649 502650 502651 502687 502688 502690 502691 502696 502698 502699 502702 502704 502706 502709 502710 502711 502712 502714 502715 502718 502722 502723 502724 502725 502726 502727 502728 502730 502731 502732 502733 502734 502735 502736 502737 502738 502739 502740 502741 502742 502744 502745 502746 502747 502749 502750 502753 502757 502760 502761 502763 502764 502765 502766 502767 502770 502771 502772 502775 502776 502781 502782 502784 502789 502791 502792 502794 502795 502797 502799 502801 502802 502803 502804 502805 502807 502808 502809 502811 502812 502814 502815 502816 502817 502818 502820 502821 502824 502832 502835 502842 502843 502844 502846 502847 502850 502851 502852 502853 502854 502855 502856 502858 502859 502860 502861 502862 502863 502864 502865 502867 502868 502869 502870 502872 502873 502875 502877 502879 502880 502881 502882 502883 502884 502885 502886 502887 502888 502889 502890 502891 502892 502893 502894 502895 502896 502897 502900 502901 502902 502903 502904 502905 502906 502907 502908 502909 502911 502912 502913 502914 502915 502916 502917 502918 502920 502921 502923 502924 502925 502926 502927 502929 502930 502931 502932 502933 502934 502935 502936 502937 502938 502939 502940 502941 502942 502943 502944 502945 502946 502947 502948 502949 502950 502951 502953 502954 502955 502956 502957 502958 502959 502960 502962 502963 502964 5

UPC codes

07630002806091, 07630002813549

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.