FDA (Devices) recall action 91055
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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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.
The agency’s own wording, quoted from the enforcement report.
Visionsense, Ltd. issued a voluntary Class II recall of the VS3 Iridium infrared fluorescence microscope affecting 34 units with US Nationwide distribution.
Visionsense is recalling 205 units of its VS3 Iridium microscope because optical fiber cables may become damaged during handling, causing loss of function and outer cable heating or melting.
Visionsense VS3 Iridium beam combiners may develop damaged optical fiber cables through handling or bending, causing loss of functionality and potential cable heating or melting. Affected units were distributed nationwide in the US.