FDAFDA · Food and drugs·Recall number Z-0181-2025
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Published October 30, 2024 · Recall initiated: August 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: 04953170420191; Serial Numbes: 2304049 2404551 2404550 2404541 2404537 2404577 2404576 2404574 2404571 2404570 2404569 2404568 2404567 2404566 2404565 2404564 2404563 2404562 2404561 2404560 2404559 2404552 2404547 2404626 2404625 2404624 2404623 2404620 2404619 2404618 2404617 2404616 2404615 2404614 2404613 2404612 2404611 2404610 2404609 2404608 2404607 2404606 2404605 2404604 2404603 2404601 2404599 2404598 2404602 2404600 2404597 2404596 2404595 2404594 2404592 2404591 2404590 2404589 2404588 2404587 2404586 2404584 2404582 2404581 2404580 2404757 2404691 2404686 2404685 2404679 2404678 2404674 2404673 2404672 2404665 2404657 2404655 2404653 2404649 2404647 2404688 2404681 2404727 2404722 2404719 2404710 2404708 2404699 2404643 2404642 2404641 2404640 2404638 2404637 2404636 2404635 2404634 2404633 2404631 2404628 2404621 2404746 2404742 2404741 2404732 2404729 2404723 2404713 2404712 2404709 2404705 2404704 2404703 2404702 2404701 2404700 2404698 2404683 2404680 2404675 2404728 2404726 2404725 2404724 2404721 2404720 2404718 2404716 2404715 2404714 2404711 2404707 2404697 2404694 2404693 2404692 2404690 2404689 2404684 2404677 2404660 2404656 2404644 2404717 2404706 2404817 2404816 2404812 2404805 2404804 2404803 2404801 2404800 2404798 2404796 2404795 2404794 2404790 2404788 2404797 2404793 2404787 2404785 2404781 2404780 2404775 2404774 2404773 2404772 2404771 2404769 2404767 2404765 2404761 2404792 2404791 2404789 2404786 2404784 2404783 2404782 2404779 2404778 2404777 2404776 2404770 2404766 2404764 2404763 2404573 2404914 2404909 2404907 2404903 2404902 2404901 2404900 2404899 2404897 2404895 2404890 2404842 2404829 2404834 2404850 2404828 2404824 2404823 2404822 2404821 2404820 2404819 2404818 2404813 2404811 2404810 2404808 2404806 2404799 2404843 2404841 2404840 2404839 2404838 2404837 2404836 2404835 2404833 2404832 2404831 2404830 2404827 2404826 2404825 2404892 2404889 2404888 2404885 2404883 2404874 2404868 2404898 2404870 2404896 2404893 2404887 2404886 2404884 2404882 2404881 2404880 2404879 2404878 2404877 2404876 2404875 2404873 2404872 2404871 2404869 2404867 2404866 2404865 2404864 2404863 2404862 2404861 2404859 2404858 2404857 2404856 2404855 2404854 2404853 2404852 2404851 2404849 2404848 2404847 2404846 2404845 2404844 2404860 2404762 2404760 2404759 2404758 2404756 2404755 2404754 2404753 2404752 2404751 2404749 2404748 2404747 2404740 2404738 2404736 2404735 2404730 2404696 2404632 2404630 2404627 2404750 2404745 2404744 2404743 2404739 2404737 2404734 2404733 2404731 2404687 2404629 2404938 2404936 2404935 2404932 2404930 2404928 2404926 2404925 2404924 2404923 2404922 2404921 2404919 2404918 2404917 2404916 2404912 2404908 2404915 2404913 2404911 2404906 2404905 2404904 2404894 2404891 2404954 2404951 2404949 2404948 2404946 2404931 2404927 2404962 2404961 2404960 2404957 2404956 2404955 2404952 2404950 2404947 2404945 2404944 2404943 2404942 2404941 2404940 2404939 2404937 2404934 2404910 2405018 2405017 2405013 2405008 2405007 2405006 2405005 2405004 2405002 2405001 2405000 2404999 2404994 2404993 2404768 2404333 2405014 2405009 2404992 2404991 2404985 2404984 2404983 2404982 2404980 2404978 2404977 2404976 2404975 2404974 2404972 2404971 2404970 2404969 2404300 2405048 2405047 2405046 2405045 2405044 2405043 2405041 2405040 2405039 2405038 2405036 2405035 2405034 2405032 2405031 2405029 2405022 2405015 2405069 2405067 2405066 2405064 2405063 2405061 2405060 2405056 2405042 2405079 2405078 2405074 2405073 2405071 2405070 2405068 2405065 2405019 2405016 2405011 2405010 2405003 2404998 2404997 2404996 2404995 2404990 2404989 2404987 2404986 2404981 2404979 2404973 2404967 2404966 2404965 2404964 2404959 2404958 2404814 2404676 2405012 2405085 2405084 2405081 2405077 2405072 2405059 2405053 2405052 2405050 2405049 2405037 2405028 2405027 2405021 2405026 2405131 2405126 2405125 2405122 2405119 2405118 2405108 2405106 2405101 2405100 2405143 2405142 2405140 2405139 2405138 2405136 2405135 2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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