VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
Medical device recall Z-0282-2023. Published in FDA’s Enforcement Report on Nov 30, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 30, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 204 units: 93 units OUS ; 111 units US how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
204 units: 93 units OUS ; 111 units US, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,738 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 17, 2022.
- FDA classified it on Nov 23, 2022.
- FDA’s Enforcement Report published it on Nov 30, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Visionsense, Ltd., of Petakh Tikva, Israel.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: N/A.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.