Medical device recalls Moderate risk

Alcon Research, Ltd. recalls LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor…

Recall date
August 11, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2448-2015
FDA classification
Class II
Brand / firm
Alcon Research, Ltd.
Sold / distributed
Worldwide Distribution - US Nationwide and the countries Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, France, Germany, Greece, Guatemala, Hungary, India, Italy, Japan, Jordan, Korea, Lebanon, Mala…

Why it was recalled

Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.

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

What was recalled

LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers)

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