Medical device recalls Moderate risk

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

Recall date
October 17, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0282-2023
FDA classification
Class II
Brand / firm
Visionsense, Ltd.
Sold / distributed
US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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