Medium RiskFDA Device

Visionsense, Ltd.: Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.; XXX

Agency Publication Date: November 23, 2022

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Affected Products

Product: VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012

UDI-DI: 18130400103489 Lot Numbes: 3784719 3784735 3784751 378-4001 378-4002 378-4003 378-4004 378-4006 378-4007 378-4008 378-4009 378-4010 378-4012 378-4013 378-4014 378-4015 378-4016 378-4017 378-4020 378-4021 378-4501 378-4502 378-4503 378-4504 378-4505 378-4506 378-4507 378-4508 378-4510 378-4511 378-4512 378-4513 378-4515 378-4529 378-4531 378-4535 378-4537 3784581 378-4582 378-4583 378-4584 378-4588 378-4589 378-4590 3784592 378-4593 378-4594 3784595 378-4596 3784599 3784601 378-4602 3784603 378-4604 3784605 3784606 3784609 3784610 3784612 3784613 3784614 3784617 378-4618 3784619 3784620 3784621 3784622 3784623 3784624 3784626 3784627 3784628 3784629 3784632 3784633 3784635 3784636 3784637 3784638 3784641 3784644 3784645 3784646 3784648 3784649 3784650 3784651 3784652 3784653 3784654 3784656 378-4657 378-4658 3784659 3784660 3784661 3784662 3784663 3784664 3784665 3784666 3784667 3784669 3784671 3784672 3784674 378-4675 3784676 378-4677 3784679 3784680 3784681 3784682 3784683 3784685 3784686 3784687 3784688 3784689 3784691 3784705 3784706 3784708 3784713 3784715 3784716 3784717 3784718 3784720 3784721 3784723 3784725 3784726 3784727 3784728 378-4729 3784731 3784732 3784733 3784734 3784736 3784738 378-4739 378-4740 378-4742 3784743 3784744 378-4745 3784746 3784752 3784753 3784755 3784757 3784758 3784759 3784760 3784761 3784762 3784763 3784764 3784765 3784766 378-4767 378-4768 378-4769 3784775 3784776 3784777 3784779 3784780 3784781 3784789 3784790 3784791 3784792 3784793 3784798 3784799 3784801 378-4805 378-4806 3784809 3784811 3784812 3784813 3784819 3784821 3784822 3784824 3784825 3784826 3784827 3784828 378-4829 3784834 3784837 3784838 3784839 3784841 378-4858 3784863 3784864 3784865 3784867 3784868

Lot Numbers:

Numbes

Product: VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012

UDI-DI: 10813040013711 Lot Numbers: Serial Number/Lot Number 378-4005 378-4514 378-4516 378-4517 378-4518 378-4519 378-4520 378-4521 378-4522 378-4523 378-4525 378-4526 378-4527 378-4528 378-4534 378-4586 3784692 3784693 3784694 3784696 3784700 3784701 3784702 3784703 3784704 3784784 3784786 3784787 3784802 3784803 3784807 3784808 3784874 3784875

Lot Numbers:

Numbers

Number

Product: VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001

UDI-DI: 18130400103625 Lot Numbers: Serial Number/Lot Number 3611111 3611161 3611191 361-0012 361-0901 361-0902 361-0903 361-0904 361-0906 361-0907 361-0908 361-0909 361-0910 361-0911 361-0913 361-0914 361-0915 361-0916 361-0917 361-0918 361-0919 361-0921 361-0922 361-0923 361-0924 361-0926 361-0929 361-0931 361-0932 361-0933 361-0937 361-0938 361-0940 361-0941 3610942 361-0943 361-0944 361-0945 3610946 3610947 3610949 3610950 3610951 3610952 3610953 361-0955 3610956 3610957 3610958 3610961 3610963 3610964 3610965 361-0966 3610968 361-0970 3610971 3610972 3610973 3610974 3610975 3610977 3610978 3610979 3610996 3610998 3610999 3611000 3611004 3611006 3611007 3611008 3611009 3611011 3611012 3611014 3611015 3611016 3611019 3611025 3611027 3611029 3611031 3611033 3611034 3611035 3611036 3611039 3611041 3611042 3611044 3611046 3611048 3611049 3611052 3611053 3611055 3611056 3611057 3611058 3611059 3611060 361-1061 3611062 3611063 3611065 361-1067 3611068 3611070 3611071 3611073 3611075 3611077 3611078 3611079 3611080 3611082 3611083 3611084 3611085 3611086 3611087 3611088 3611092 3611096 3611097 3611099 3611100 3611101 3611102 361-1103 3611104 3611106 3611108 3611109 3611110 3611112 3611113 3611114 3611116 3611117 3611118 3611119 3611120 3611121 361-1122 3611123 3611124 3611125 3611126 3611128 3611129 3611130 3611131 361-1132 3611133 3611134 3611135 3611136 3611138 3611139 3611140 361-1144 3611146 361-1148 3611149 3611152 3611153 3611154 3611156 3611157 3611158 3611159 3611162 3611167 361-1168 3611170 3611171 3611172 3611173 3611174 3611175 3611176 3611177 3611178 3611180 3611181 3611182 3611188 3611189 3611190 3611194 3611195 3611196 3611197 3611199 3611200 3611201 3611218 3611219 3611223 3611224 3611225 361-1013

Lot Numbers:

Numbers

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91055

Status: Active

Manufacturer: Visionsense, Ltd.

Manufactured In: Israel

Units Affected: 3 products (205 units: 94 units OUS; 111 units US; 34 units: 15 units OUS; 19 units US; 204 units: 93 units OUS ; 111 units US)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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